Recall Summary
| Recall number | Z-0002-2027 |
| Issued by | U.S. Food and Drug Administration |
| Date | 2026-10-21 |
| Company | Instrumentation Laboratory |
| Units affected | 1,414 |
| Severity | Class I |
Remedy: Follow the instructions in the official notice linked below. The agency record for this recall did not contain remedy text we could verify against this product, so we have not reproduced it here.
Read the official U.S. Food and Drug Administration recall notice
The instrumentation laboratory recall listed by the U.S. Food and Drug Administration on October 21, 2026 is a Class I action. It covers a lab blood test that doctors use to check for a serious reaction to the blood thinner heparin. The agency record lists the product as HemoslL AcuStar HIT-lgG(PF-4). It warns that the test could produce an invalid calibration curve. It could also show a negative mean bias of up to 47% with patient samples. As a result, test results could read lower than they should.
What the Instrumentation Laboratory Recall Covers
This recall covers one product. The FDA record lists it as “HemoslL AcuStar HIT-lgG(PF-4).” The company is Instrumentation Laboratory, which sells diagnostic tests under the HemosIL brand. The listed part number is 0009802028. The recall number is Z-0002-2027.
The record describes the product as an in vitro diagnostic. That means it tests samples, such as blood, outside the body. It is not an implant or a device worn by patients. Instead, a lab runs it on an analyzer and reports the result to a doctor.
The scope is 1,414 units. The record also marks the product “OUS only.” In most cases, that label means outside the United States. In other words, the product was meant for markets outside the U.S. Even so, the FDA lists the action in its recall database.
The agency data we reviewed does not list lot numbers or sale dates. For this reason, labs should check the official notice for lot details. For now, the part number is the most reliable way to identify the product. Typically, lab staff can find it on the kit box or reagent labels.
The Hazard and Reported Injuries
This test looks for antibodies linked to heparin-induced thrombocytopenia, or HIT. HIT is an immune reaction to heparin, a common blood thinner. It can cause low platelet counts. It can also raise the risk of dangerous blood clots. Accurate testing helps doctors decide whether to stop heparin and switch treatment.
The agency names two problems. The first is a potential invalid calibration curve. A calibration curve is how an analyzer turns a raw signal into a result. If the curve is invalid, results may not be reliable. The second problem is a negative mean bias of up to 47% with patient samples. Negative bias means results tend to read lower than the true value.
Why does a low reading matter? For example, a sample with high antibody levels could read as low. As a result, a test could look negative when it should be positive. A missed result could delay a needed change in treatment. However, doctors typically weigh lab results alongside symptoms and other test findings.
The FDA rated this a Class I recall, its most serious category. Class I applies when using the product could reasonably cause serious health problems or death. The agency record does not say whether any injuries have been reported. We make no claim either way. The key details of the instrumentation laboratory recall are below.
| Recall Number | Z-0002-2027 |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Date | October 21, 2026 |
| Company | Instrumentation Laboratory |
| Product | HemoslL AcuStar HIT-lgG(PF-4), Part Number 0009802028 (OUS only) |
| Units Affected | 1,414 units |
| Severity | Class I |
What To Do If You Own This Product
Most readers will not own this product. Labs and hospitals do. If you work in a lab, check your inventory for part number 0009802028. Compare what you have against the official notice. If you find a match, follow the notice’s instructions right away.
We have not listed the remedy on this page. The agency record for this instrumentation laboratory recall had remedy text that did not match the product. As a result, we withheld it. Please follow the instructions in the official notice instead. You can find it in the FDA device recall database. Your Instrumentation Laboratory representative can also answer questions.
If you are a patient, you may wonder whether your own HIT test was affected. Ask your doctor or hospital directly. Ask whether the lab used this product. You can also ask whether any results should be reviewed. Typically, labs keep records of which test kits they used and when.
Keep your records in a safe place. Save lab reports, discharge papers, and bills. Write down the dates you received heparin. These records can help your care team. They may also matter if you later talk to a lawyer. However, do not stop or change any medicine without medical advice.
Does a Instrumentation Laboratory Recall Mean You Can Sue?
Not by itself. A recall is a safety action. It is not a lawsuit. The instrumentation laboratory recall means a product problem was found and reported. It does not mean anyone was harmed. On its own, a recall does not create a legal claim.
A product liability claim usually needs more. Typically, you would need a real injury. You would also need evidence linking that injury to the product. For example, a claim might involve a delayed diagnosis tied to a faulty result. Diagnostic test cases can be complex. Responsibility could fall on the maker, the lab, or no one.
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We have not verified any lawsuit tied to this instrumentation laboratory recall. That could change over time. However, nothing in the agency record shows that a case exists today. We cannot promise that you have a claim. We also cannot promise any compensation.
If you believe you were harmed, speak with a licensed attorney. Many product liability lawyers offer free consultations. A lawyer can review your medical records. They can tell you whether you may be eligible to file a claim. They can also explain filing deadlines. Since this product was sold outside the U.S., local laws may apply.
How Recalls Connect to Mass Tort Cases
Recalls often show up later in court as evidence. A recall can show when a company learned of a problem. It can also describe the risk in the company’s own words. However, a recall is not proof of fault. Courts still review the full record before reaching any decision.
The Philips CPAP recall is a well-known example. In June 2021, Philips Respironics recalled millions of sleep apnea machines. The concern was sound-reducing foam that could break down. Lawsuits followed and were combined in federal court in Pennsylvania. In 2024, Philips agreed to a reported $1.1 billion personal injury settlement.
Takata airbags are another example. Some inflators could rupture and spray metal fragments. The result was the largest auto recall in U.S. history. Litigation and a federal criminal case followed. In both cases, the recalls helped shape the evidence that later came out in court.
Still, not every recall leads to litigation. In most cases, a recall ends with corrective steps and no lawsuits. For this instrumentation laboratory recall, it is too early to say what will happen. We will update this page if verified developments occur.
Frequently Asked Questions
What is the instrumentation laboratory recall?
It is FDA recall Z-0002-2027, a Class I action dated October 21, 2026. It covers the HemoslL AcuStar HIT-lgG(PF-4) test, part number 0009802028. The concern is a possible invalid calibration curve or a negative bias of up to 47%.
Was this test sold in the United States?
The agency record marks the product “OUS only,” which typically means outside the United States. The recall covers 1,414 units. Check the official notice for distribution details.
Have any injuries been reported?
The agency record does not say whether injuries have been reported. We do not claim either way. If you have concerns about a past test result, talk to your doctor.
Where can I find the remedy for this instrumentation laboratory recall?
Follow the instructions in the official FDA notice linked on this page. We withheld the remedy because the agency record had text that did not match this product. Instrumentation Laboratory can also help affected labs.
Were You Injured by a Recalled Product?
A recall by itself is a safety action, not a legal claim. However, if a recalled product caused a real injury, you may be eligible to pursue compensation. A licensed attorney can review your situation at no upfront cost — most work on contingency, meaning you pay nothing unless you recover.
Official Sources & Resources
Verify every recall against the issuing agency before acting:
- U.S. Food and Drug Administration: official recall database — the record of truth for this notice
- CPSC: cpsc.gov — household goods, toys, furniture, appliances
- FDA: fda.gov — food, drugs, and medical devices
- NHTSA: nhtsa.gov — vehicles, tires, and child car seats
- USDA FSIS: fsis.usda.gov — meat, poultry, and egg products
Content last reviewed October 2026. This is general educational information, not legal advice. If you notice outdated information, please contact us.
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Attorney Advertising. The information on this page is provided for general informational purposes only and does not constitute legal advice. A product recall is a safety action by a manufacturer or regulator and does not by itself establish liability or create a legal claim. No attorney-client relationship is created by accessing or using this content. Every case is unique. If you believe you were harmed by a recalled product, consult a licensed attorney in your jurisdiction.