Corporate Accountability Report
Filed: January 13, 2026 · Northern District of California
Abbott Diabetes Care · Class Action · 2024–2026
Abbott Hid Deadly Sensor Defects from Millions of Diabetics
While diabetics trusted Abbott’s FreeStyle Libre 3 glucose monitors with their lives, Abbott concealed a known manufacturing defect that triggered false readings, serious injuries, and seven deaths.
TL;DR
Abbott manufactured and sold FreeStyle Libre 3 glucose sensors it knew were defective, reporting dangerously false blood sugar levels to diabetics who relied on those readings to dose insulin, eat, and stay alive. Abbott concealed the defect even as 736 serious injuries and seven deaths accumulated in its own records. Only after the FDA stepped in with a public alert did Abbott act. Approximately 3 million defective devices reached patients across the United States, roughly half of which had already been used before the company finally disclosed the danger.
This is not a bureaucratic oversight. Abbott chose silence over safety, and people paid for it with their lives.
Key Numbers
3M
Defective sensors distributed nationwide
1.5M
Sensors already used before recall disclosure
736
Serious adverse injuries reported to Abbott
7
Deaths potentially linked to defective sensors
18 mo.
Span of shifting defects from same production line
$5M+
Minimum amount in controversy (CAFA threshold)
Breakdown of Misconduct
Core Allegations
What Abbott did · 6 points
| 01 | Abbott manufactured, marketed, and sold the FreeStyle Libre 3 and Libre 3 Plus sensors while concealing a manufacturing defect that caused devices to report falsely low glucose readings, even when patients’ actual blood sugar was normal or dangerously elevated. | high |
| 02 | Abbott actively marketed the sensors as the “world’s smallest and most accurate 14-day glucose sensor” with a sub-8% mean absolute relative difference (MARD), implicitly promising accuracy that the defective devices could not deliver. | high |
| 03 | Abbott knew about the defect through its own internal testing and market surveillance, identifying that sensors from a specific production line systematically produced inaccurate glucose readings, yet failed to inform consumers or the public. | high |
| 04 | Abbott did not publicly disclose the defect or initiate corrective action until November 24, 2025, by which point 736 serious injuries and seven deaths had already been reported to the company and were known internally. | high |
| 05 | Abbott’s marketing stated that the sensors “eliminated the need for fingersticks” and empowered patients to make confident diabetes management decisions, representations that were false and dangerous for patients relying on defective readings. | high |
| 06 | Plaintiff Bijoy Shroff received a letter from CVS on December 3, 2025, informing him that sensors he had purchased were among those identified as defective and subject to recall, and he had already used them for blood glucose management decisions. | med |
Public Health and Safety
Unsafe products and life-threatening health risks · 6 points
| 01 | The FDA determined that the sensors are defective due to a manufacturing flaw and that inaccurate readings pose a serious safety risk because they may prompt users to take unnecessary corrective actions or delay appropriate treatment, increasing the risk of severe hypoglycemia, loss of consciousness, seizures, or death. | high |
| 02 | The FDA issued an Early Alert on December 2, 2025, classifying the issue as a serious medical device safety concern after Abbott reported hundreds of serious adverse health events, including seven deaths potentially associated with the defective sensors. | high |
| 03 | The sensors are FDA-approved for individuals aged four and older, meaning children as young as four were among the patients exposed to dangerously inaccurate glucose readings from defective devices. | high |
| 04 | Diabetics rely on accurate glucose readings to make critical treatment decisions including insulin dosing calculations, carbohydrate intake, meal timing, medication choices, and activity levels. False readings corrupt every one of those decisions. | high |
| 05 | Approximately 1.5 million of the 3 million defective sensors had already expired or been used by patients by the time Abbott disclosed the defect in November 2025, meaning those patients made treatment decisions based on false readings with no warning whatsoever. | high |
| 06 | The defect causes sensors to report falsely low readings, which can lead patients to believe their blood sugar is safe or even low when it is actually elevated, making the error particularly dangerous because it masks the true emergency. | high |
Regulatory Failures
How oversight broke down · 5 points
| 01 | In July 2024, Abbott recalled sensors for providing incorrect high readings. In September 2024, the FDA classified that recall as a Class I recall, its most serious designation, reserved for products presenting a reasonable probability of causing serious adverse health consequences or death. | high |
| 02 | The November 2025 recall for incorrect low readings involves the same production line as the July 2024 recall, demonstrating that Abbott’s corrective and preventative actions required under FDA regulations (21 CFR 820.100) were entirely ineffective. | high |
| 03 | The defects shifted from dangerously high inaccuracies to dangerously low inaccuracies within 18 months on the same production line, demonstrating a systemic failure in Abbott’s quality controls, not a one-time manufacturing error. | high |
| 04 | Abbott continued selling and advertising the defective sensors as accurate and effective even after the defect was internally known, violating its duty to disclose material safety information and failing consumers who had no way to independently identify the danger. | high |
| 05 | The complaint alleges that Abbott failed to provide immediate notice of the defect and related safety risks associated with normal use, actively concealing the defect from patients even as it continued advertising the sensors as reliable life-management tools. | med |
Profit Over People
Revenue prioritized over ethics and safety · 5 points
| 01 | Abbott has benefited from selling at unjust profit defective FreeStyle glucose monitors with artificially inflated prices sustained by its concealment of defects, causing patients to overpay for devices that could not deliver the safety and accuracy promised. | high |
| 02 | Abbott actively concealed material defects for the purpose of inducing patients to purchase its sensors rather than competitors’ glucose monitors, prioritizing market share over patient safety. | high |
| 03 | Patients paid out of pocket not only for the defective sensors but also for related accessories (overpatches, adhesives, test strips, insulin pumps, and Freestyle-compliant cell phones) required by or made necessary because of the defective sensors. | med |
| 04 | The complaint alleges that Abbott engaged in opportunistic, unethical, and immoral conduct by profiting from sensors it knew were defective or highly subject to defect, and that retaining those profits would be inequitable, unconscionable, and unlawful. | high |
| 05 | Had Abbott disclosed the defects in its advertisements or other materials, patients and any reasonable consumer would have been aware of them and would not have purchased the sensors or additional accessories, or would have paid less for them. | med |
Corporate Accountability Failures
Delayed disclosure and concealment of known harm · 5 points
| 01 | Abbott has still not disclosed the full scope of the defects to anyone outside the company. The complaint alleges it has taken insufficient actions to inform consumers about the true nature of these defects in the sensors. | high |
| 02 | The defect was not disclosed in any sales documents, displays, advertisements, warranties, manuals, or on Abbott’s website, leaving patients with no way to know they were using a life-threatening device. | high |
| 03 | Abbott possessed exclusive knowledge of the defects that was not available to consumers, creating a power imbalance that the company exploited to continue sales while patients remained unaware of the risks they were taking. | high |
| 04 | Abbott made partial representations (“no fingersticks,” “accuracy,” “reliability,” “safety”) that were misleading in the absence of disclosure about the known defects, a practice the complaint identifies as a basis for the duty to disclose. | med |
| 05 | Class members were deceived through no fault or lack of diligence of their own. The complaint argues all statutes of limitations have been tolled because Abbott’s concealment prevented consumers from discovering the truth through any reasonable investigation. | med |
Timeline of Events
July 2024
Abbott recalls FreeStyle Libre sensors for producing incorrect high glucose readings. The affected production line is the same one that will produce the second wave of defective sensors.
Sept 2024
The FDA classifies the July 2024 recall as a Class I recall, its most serious designation, indicating a reasonable probability of causing serious adverse health consequences or death.
2024–2025
Abbott identifies through internal testing that sensors from the same production line are producing defective low glucose readings. Serious injuries and deaths accumulate internally. Abbott does not disclose the defect to the public.
Nov 24, 2025
Abbott finally discloses the low-reading defect and initiates corrective action, more than a year after the production line was first recalled and after 736 serious injuries and seven deaths had been reported internally.
Dec 2, 2025
The FDA issues a public Early Alert warning consumers about the defective sensors, classifying the situation as a serious medical device safety concern.
Dec 3, 2025
CVS sends letters to customers, including plaintiff Bijoy Shroff, notifying them that sensors they had purchased are among those subject to recall.
Jan 13, 2026
Class action complaint filed in the Northern District of California on behalf of Bijoy Shroff and all U.S. purchasers of FreeStyle Libre 3 and Libre 3 Plus sensors from the affected production line.
Direct Quotes from the Legal Record
QUOTE 1
Abbott knew and concealed
Core Allegations
“Abbott failed to publicly disclose the defect or initiate a broad corrective action until November 24, 2025, long after the defect has manifested in the market, including after 736 serious injuries and seven deaths had been reported to, and were known by, Abbott.”
💡 Abbott had a body count in its records and chose silence. This single sentence is the core of the concealment claim.
QUOTE 2
The danger posed by false readings
Public Health and Safety
“These inaccurate readings pose a serious safety risk because they may prompt users to take unnecessary corrective actions or delay appropriate treatment, thereby increasing the risk of severe hypoglycemia, loss of consciousness, seizures, or death.”
💡 This is from the FDA’s own determination. The potential consequences listed are not hypothetical; they are clinical realities for people with diabetes.
QUOTE 3
Same broken line, second recall
Regulatory Failures
“The shifting defects—going from dangerously high to dangerously low inaccuracies within 18 months—demonstrates a systemic failure in Abbott’s quality controls and a severe lack of effective Corrective and Preventative Actions required by the FDA.”
💡 This was not a one-time mistake. Abbott failed to fix a known problem and then watched it produce a second, equally dangerous defect from the exact same source.
QUOTE 4
Abbott’s marketing claims vs. reality
Core Allegations
“Abbott marketed the Sensors as having unsurpassed accuracy with the world’s smallest and most accurate 14-day glucose sensor, implicitly warranting consistent and reliable performance.”
💡 Abbott sold the product on the promise of accuracy. Accuracy is the one thing the product could not provide. That gap between promise and product is the foundation of the fraud claim.
QUOTE 5
No disclosure anywhere, ever
Corporate Accountability Failures
“Such information is not adequately disclosed in any sales documents, displays, advertisements, warranties, manuals, or on Abbott’s website.”
💡 Patients had no path to the truth. Every touchpoint with the product was a site of continued concealment.
QUOTE 6
Abbott’s unjust profit from defective devices
Profit Over People
“Abbott has benefited from selling at an unjust profit defective FreeStyle CGMs that had artificially inflated prices due to Abbott’s concealment of defects.”
💡 The concealment was not just a safety failure. It was the mechanism that sustained the price premium. Abbott profited directly from keeping patients in the dark.
QUOTE 7
Duty to disclose: three grounds
Corporate Accountability Failures
“Defendants had a duty to disclose material facts because: (1) they possessed exclusive knowledge of the defects not known to consumers; (2) they actively concealed the defects while making partial representations… that were misleading absent disclosure; and (3) the defects go to safety—a central characteristic of a medical device.”
💡 The complaint lays out three independent legal grounds for Abbott’s duty to disclose. Abbott failed on all three, simultaneously and over an extended period.
QUOTE 8
Deception designed to block competition
Profit Over People
“Abbott actively concealed material information about these defects in the Sensor for the purpose of inducing Plaintiff and the other Class members to acquire the Sensor or related accessories, rather than using competitors’ glucose monitors.”
💡 Abbott weaponized the information asymmetry to lock patients into its ecosystem. The concealment was not passive oversight; it was a market strategy.
Commentary
How serious is this lawsuit?
▾
This is not a frivolous consumer complaint. The FDA issued a Class I recall for the predecessor defect on the same production line, its most serious recall classification, reserved for products posing a reasonable probability of causing serious harm or death. Seven people may have died. The class of potential plaintiffs numbers in the millions. The legal claims include fraudulent concealment, unjust enrichment, and violations of both California and Florida consumer protection statutes. This is a serious corporate accountability case with substantial factual and legal backing.
What did Abbott actually know, and when?
▾
According to the complaint, Abbott knew about the defect through its own internal testing and market surveillance. It identified that sensors from a specific production line were systematically producing inaccurate glucose readings. This was not a surprise discovered late in the game. The same production line had already caused a Class I recall in July 2024 for the opposite problem (incorrect high readings). Abbott had direct, internal knowledge of the defect’s source and chose not to act swiftly enough to protect the people depending on the product.
Why does a false glucose reading matter so much?
▾
For people with diabetes, a glucose reading is not a data point. It is a treatment instruction. If the reading says blood sugar is low when it is actually high, a patient might eat carbohydrates or withhold insulin when the real emergency is the opposite. If the reading says blood sugar is safe when it is actually dropping, a patient may not take the corrective action needed to avoid a hypoglycemic crisis. These errors can cause seizures, loss of consciousness, permanent neurological damage, and death. Abbott told patients this device could replace fingerstick testing entirely. That is a position of profound responsibility, and Abbott treated it as a marketing advantage rather than a safety obligation.
Why did it take so long for this to come to light?
▾
Abbott possessed exclusive knowledge of the defect. Patients had no independent way to verify whether their sensor was malfunctioning unless they happened to cross-check readings against a fingerstick meter. Many patients trusted the sensor because they had been told it was accurate enough to replace the fingerstick. Abbott continued advertising the sensors as accurate throughout the period of concealment. The company’s marketing actively discouraged the backup verification that might have revealed the problem sooner. This is the architecture of concealment: remove the check, sell the promise, hide the defect.
Is this an isolated incident or a pattern?
▾
The complaint documents a clear pattern. The same production line produced a defect causing dangerously high readings (recalled July 2024, Class I in September 2024) and then produced a defect causing dangerously low readings (disclosed November 2025). Abbott’s corrective and preventative actions, required by federal regulations, failed entirely. Within 18 months, the same source produced two distinct, life-threatening failures. That is not a manufacturing anomaly. That is systemic quality control failure, and it unfolded while Abbott continued selling the product and promoting its accuracy.
Who is most harmed?
▾
The people most harmed are diabetics who depend on continuous glucose monitoring to manage a disease that can kill without warning. They are Type 1 and Type 2 diabetics, and their caregivers, including parents of diabetic children as young as four years old. These are people who made the considered choice to use a more sophisticated monitoring tool because Abbott told them it was better, more accurate, and liberating. They are also people who paid out of pocket for sensors and related accessories, often at significant personal expense. They were defrauded of their money and placed at serious medical risk simultaneously.
What can I do to prevent this from happening again?
▾
If you or someone you care for uses a FreeStyle Libre 3 or Libre 3 Plus sensor, check the FDA recall database and contact your pharmacy or healthcare provider to determine whether your sensors are from the affected production lot. You can also report adverse events directly to the FDA through its MedWatch program. More broadly, contact your elected representatives and urge stronger enforcement of medical device recall requirements with faster timelines for mandatory public disclosure. Support legislation that requires medical device manufacturers to notify patients immediately when internal safety data reveals a serious defect. Corporate silence is not a protected business strategy when people’s lives are at stake.
What does this case reveal about how corporate accountability works in the medical device industry?
▾
It reveals that the current system allows corporations to self-report defects on their own timeline, with no mandatory immediate public notification when adverse event data reaches a threshold of serious harm. Abbott accumulated 736 injuries and seven deaths internally before going public. Under current rules, that internal accumulation period is not clearly illegal. The law requires companies to report to the FDA, but mass public disclosure timelines are murkier. This case, if it succeeds, would create precedent that companies cannot use their exclusive knowledge of a defect as a business advantage. That is a necessary precedent. Until it exists firmly, the incentive structure rewards delay.
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