What It Actually Costs to Trust the Wrong Number

Picture waking up at 3 a.m. because your phone buzzes. The sensor on your arm says your glucose is fine. You go back to sleep. You trust the device because you were told, repeatedly and loudly, that it was the most accurate glucose monitor ever made. You were told you didn’t need to prick your finger anymore. You were told the science was settled. You paid for that certainty.

Now picture that the number on your phone is a lie. Not an accidental lie. A manufactured one. The kind that comes from a production line that the manufacturer already knew was broken.

For people managing Type 1 or Type 2 diabetes, blood sugar is not a background statistic. It is the central fact of every single day. Every meal, every workout, every drink of juice, every dose of insulin runs through that number. Parents of diabetic children spend their nights watching it on a screen so they don’t have to watch their child seize in a hospital bed. Adults who have lived with the disease for decades develop an almost unconscious relationship with their readings, a constant low-level accounting that never fully turns off.

Abbott sold them peace of mind. The company’s marketing promised that the FreeStyle Libre 3 eliminated the need for fingerstick tests entirely. That is a meaningful promise. Fingersticks are painful, they require supplies, they interrupt every meeting and every classroom and every dinner. The CGM was supposed to be freedom. The company called it the world’s smallest sensor. It touted a Mean Absolute Relative Difference of 7.9%, a clinical accuracy measurement, and advertised it as the first 14-day sensor to break below 8%. They made people feel safe in a way that cost them their vigilance.

When a sensor reports a falsely low reading, the body is telling the device one thing and the device is lying back. A person whose blood sugar is actually elevated but whose sensor shows normal may skip the corrective dose of insulin. They may eat a meal without adjusting. They may fall asleep without checking again because the machine told them they were fine. Untreated hyperglycemia can escalate into diabetic ketoacidosis. Repeated episodes damage organs. And in the acute worst case, a falsely low reading can cause someone to consume sugar or carbohydrates to “correct” a low that doesn’t exist, pushing an already elevated sugar even higher.

Seven people died. The complaint does not name them. It cannot. Their identities are inside Abbott’s adverse event reporting, a paper trail the company was legally required to maintain and that regulators reviewed before issuing the December 2025 alert. But behind each of those seven deaths is a person who put a sensor on their body, looked at a number, and made a decision that the number led them toward. They trusted technology that a corporation knew was broken and chose not to recall.

The 736 people counted as “serious injuries” in that same reporting are a number. In reality they are individual hospitalizations, emergency room visits, seizures, losses of consciousness, moments where someone’s family watched them go down and called 911. Each of those events changed something permanently: a person’s confidence in their own body, a family’s trust in a medical device, a child’s fear of the thing their parent straps on every morning.

Abbott kept selling. The same production line that was recalled in July 2024 for the opposite problem, dangerously high readings, was still producing sensors. The company apparently made changes to that line that overcorrected in the other direction. Instead of fixing the systemic failure in their quality controls, they shifted the direction of the error. Consumers paid for sensors from that line in 2024 and 2025 without ever being told any of this. They were still seeing the “world’s most accurate” marketing when they swiped their card.

The lawsuit was filed by Bijoy Shroff, a Florida resident who purchased both the FreeStyle Libre 3 and the FreeStyle Libre 3 Plus. He found out his sensors were defective not from Abbott, but from a letter CVS sent him on December 3, 2025, the day after the FDA issued its public alert. Abbott had been sitting on knowledge of the defect while Shroff and millions of others used the sensors to make treatment decisions. He experienced dangerously inaccurate readings compared to fingerstick measurements. He was the canary. There were millions of others.

What the Complaint Actually Says: Direct from the Document

These are verbatim quotes from the class action complaint filed January 13, 2026 in the U.S. District Court, Northern District of California (Case No. 3:26-cv-00351). No paraphrase. No spin.

“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.”

Complaint, ¶22

• This paragraph establishes that Abbott had internal knowledge of 736 serious adverse events and 7 deaths before it acted. The phrase “reported to, and were known by, Abbott” is legally significant: it closes the door on any future claim that the company was unaware of the harm being caused.
• The FDA’s Medical Device Reporting regulations (21 CFR Part 803) require manufacturers to report adverse events within 30 days. The complaint implies Abbott was receiving and logging these reports while simultaneously continuing to sell and market the sensors as the world’s most accurate.

“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.”

Complaint, ¶29

• This is the most damaging structural allegation in the complaint. It links the July 2024 recall (Class I, for dangerously high readings) and the November 2025 recall (for dangerously low readings) to the same production line, establishing a pattern rather than an isolated incident.
• The reference to 21 CFR § 820.100 is a citation of the FDA’s required Corrective and Preventive Action (CAPA) regulations. Abbott was legally obligated to have a functioning CAPA system in place. The complaint’s position is that the second recall proves that system failed entirely.
• The phrase “severe lack of effective Corrective and Preventative Actions” translates plainly: Abbott fixed nothing. It changed the direction of the error.

“Abbott actively concealed the defects from consumers, as alleged above… Abbott has still not disclosed the truth about the full scope of these defects to anyone outside of the company. It has taken insufficient actions to inform consumers about the true nature of these defects in the Sensors.”

Complaint, ¶39(a) and ¶39(c)

• The complaint distinguishes between the limited recall notice Abbott issued and a full disclosure of the defect’s scope. This matters for damages: consumers who weren’t reached by the recall notice continued using defective sensors after Abbott had internal knowledge of the problem.
• The allegation that Abbott “has still not disclosed the truth about the full scope” suggests the recall announcement itself was incomplete or misleading, a potential basis for additional fraud claims as discovery proceeds.

“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 publicly touted that the Sensors achieved an overall mean absolute relative difference (MARD) of 7.9%… and even touted that the Sensors’ efficacy eliminated the need for fingersticks.”

Complaint, ¶¶18–20

• Marketing that tells diabetics they no longer need fingerstick tests is not casual advertising copy. It is a safety claim. By telling consumers the device was accurate enough to replace manual glucose testing, Abbott actively removed the safeguard that would have caught the sensor’s inaccurate readings.
• The MARD claim of 7.9% was used as a competitive differentiator. The complaint’s position is that this figure was meaningless or fraudulent for sensors manufactured on the defective production line, which systematically reported falsely low values.

“Approximately 3 million Sensors manufactured on the offending production line were distributed in the United States and remain potentially in circulation. Abbott has disclosed that about half of those Sensors, around 1.5 million, had expired or been used by patients by the time the defect was disclosed in November.”

Complaint, ¶¶30–31

• Three million sensors distributed. 1.5 million already used or expired before any public disclosure. This means roughly half the affected population never had the opportunity to make an informed decision to stop using the device, even after Abbott had internal knowledge of the defect.
• The 1.5 million sensors already used represent the full extent of the unrecoverable harm. Those readings have already been taken. Those treatment decisions have already been made. There is no way to retroactively correct them.

What Abbott Told Consumers vs. What Was Actually Happening

Abbott’s marketing claims were specific, measurable, and medically significant. Every one of them was made while the company had internal knowledge of a defect affecting a production line responsible for millions of sensors.

Who Actually Gets Hurt When Medical Devices Lie

Public Health: The Human Cost of Falsified Accuracy Claims

The FDA classified the July 2024 recall as Class I, its most serious designation, before the November 2025 recall for the opposite error type. The documented consequences of defective continuous glucose monitoring are severe and irreversible.

• The FDA determined that falsely low glucose readings pose a “serious safety risk” because they may prompt users to take “unnecessary corrective actions or delay appropriate treatment.” In practice, this means a person with elevated blood sugar who sees a normal reading on their sensor may skip an insulin dose, eat without adjusting, or go to sleep without follow-up. The consequences of untreated hyperglycemia include diabetic ketoacidosis, organ damage, and death.
• Seven deaths were reported to Abbott and linked to the defective sensors prior to the public recall announcement of November 24, 2025. These adverse events were known by the company and did not trigger immediate corrective action.
• 736 serious injuries were reported to Abbott before public disclosure. Serious injuries under FDA adverse event reporting standards include hospitalizations, life-threatening conditions, and permanent impairment. Each of these 736 individuals used a device they had been told was the world’s most accurate.
• The sensors are FDA-approved for use in children aged four and older. The complaint does not specify what proportion of the 3 million distributed sensors were used by pediatric patients, but the population includes parents monitoring glucose in children who cannot self-advocate. A falsely reassuring reading in a sleeping child is a catastrophic failure condition.
• The FDA’s Class I recall classification for the July 2024 event specifically listed “severe hypoglycemia, seizures, coma, permanent neurological injury and death” as foreseeable consequences. Abbott’s own quality control system failed to prevent the production line from continuing to generate defective sensors after that recall.
• Abbott’s marketing explicitly discouraged the one redundant safety check that could catch sensor error: the fingerstick test. By promoting the device as a fingerstick replacement, Abbott systematically reduced consumers’ likelihood of catching inaccurate readings through independent verification.

Economic Inequality: Who Absorbs the Cost When a Medical Device Company Lies

The financial harm from Abbott’s concealment does not fall evenly. Diabetics who rely on continuous glucose monitoring are, by definition, a population with significant ongoing medical expenses. The cost of deception compounds on top of costs that are already crushing.

• The complaint establishes that consumers “paid out of pocket” for the sensors. For people on high-deductible health plans, or uninsured, the FreeStyle Libre 3 represents a significant recurring expense. Sensors are designed for 14-day use, meaning users purchase replacements continuously. An unknown number of those replacements were defective units from the affected production line.
• The complaint notes that class members also purchased related accessories including “overpatches, adhesives, additional test strips, insulin pumps, and/or Freestyle-compliant cell phones.” These are additional costs incurred specifically to use the Abbott sensor ecosystem. All of that spending was made in reliance on accuracy claims Abbott knew were false for a portion of its products.
• Plaintiff Bijoy Shroff, who represents the class, discovered his sensors were defective via a CVS letter dated December 3, 2025. This means he learned about the defect from a pharmacy chain, not from the manufacturer. The delayed and indirect notification structure meant that low-income or less connected consumers, those less likely to receive or act on a recall letter, may have continued using defective devices even longer.
• Abbott’s unjust enrichment count in the complaint states the company “benefited from selling at an unjust profit defective FreeStyle CGMs that had artificially inflated prices due to Abbott’s concealment of defects.” The premium pricing of the device was tied directly to the accuracy and reliability claims that the company knew were not universally true for the affected production run.
• Low-income diabetics who cannot afford the multiple-redundancy approach of supplementing sensors with frequent fingerstick testing were disproportionately harmed. They had fewer ways to catch the inaccurate readings and more to lose from a gap in coverage during the recall and replacement process.

Putting the Numbers in Human Terms

How to Hold Abbott Accountable and Protect Yourself

This class action is in its earliest stage. Here is who you need to watch, what you can do right now, and where to put your energy if you want to push this further than a settlement check.

The Corporate Entities Named in the Suit

• Abbott Diabetes Care Inc.: Delaware corporation, principal place of business in Alameda, California. The direct manufacturer and distributor of the FreeStyle Libre 3 sensors.
• Abbott Laboratories: Illinois corporation, principal place of business in Abbott Park, Illinois. The parent company named as a co-defendant.

Regulatory Watchlist

• The U.S. Food and Drug Administration (FDA) issued the December 2, 2025 Early Alert. You can file a MedWatch adverse event report directly with the FDA at fda.gov/safety/medwatch if you believe you were harmed by a defective sensor. Your report creates an official record and adds to the evidentiary database regulators use to escalate enforcement.
• The Federal Trade Commission (FTC) has jurisdiction over deceptive marketing claims. Abbott’s advertising boasting of “world’s most accurate” and “eliminates fingersticks” while knowing of the production defect is exactly the type of false advertising the FTC can investigate. File a complaint at reportfraud.ftc.gov.
• The Consumer Financial Protection Bureau (CFPB) is relevant if consumers took on medical debt or used financial products to pay for the defective sensors. If your insurer or a financing company is involved in your sensor purchases, that adds another avenue.
• Your State Attorney General can pursue enforcement under state consumer protection law. The complaint already invokes California’s CLRA and Florida’s Unfair and Deceptive Trade Practices Act. If you are in another state, contact your AG’s consumer protection division. Many states have parallel statutes.

If You Used a FreeStyle Libre 3 or Libre 3 Plus Sensor

• Stop using any sensors from the affected lot numbers immediately. The FDA advises that affected sensors be discontinued and replaced. Contact Abbott or your pharmacy for replacement information. Do not wait for a letter.
• Keep every receipt, packaging, and record of purchase for the sensors and all related accessories you bought. The class action seeks recovery for out-of-pocket costs including overpatches, adhesives, test strips, and Freestyle-compatible phones. Your documentation is your claim.
• If you experienced abnormal glucose readings, a medical event, or sought emergency care while using these sensors, document everything and speak with a physician about whether the event may be linked to sensor inaccuracy. File a MedWatch report with the FDA. Your report matters.
• Monitor ClassAction.org for updates on case No. 3:26-cv-00351 in the Northern District of California. Class membership and any opt-out deadlines will be established as the case progresses. You do not need to hire a lawyer to be included in a class action, but you should know your options.

Mutual Aid and Collective Action Beyond the Lawsuit

• Diabetes advocacy organizations including the American Diabetes Association and JDRF (formerly the Juvenile Diabetes Research Foundation) have policy and advocacy arms. Contact them specifically to push for mandatory real-time adverse event disclosure requirements for CGM manufacturers. The current system allowed Abbott to accumulate 736 injuries and 7 deaths before acting. That system needs to change.
• If you are part of a diabetes patient community, online or in-person, share this information and the FDA MedWatch link. People using these sensors right now may not have received a recall letter. Your reach is faster than Abbott’s notification process demonstrated itself to be.
• Push your congressional representatives to fund and staff the FDA’s device safety division adequately. Under-resourced regulators cannot catch these failures fast enough. The FDA issued its alert eight days after Abbott’s recall announcement. Stronger pre-market surveillance and faster post-market enforcement requires political will and budget.
• If you are a healthcare provider, patient advocate, or pharmacist: the complaint’s allegation that Abbott “has still not disclosed the truth about the full scope of these defects to anyone outside of the company” means your patients may be using defective sensors without knowing it. Proactive outreach through clinical channels is the fastest way to reduce ongoing harm.