Instrumentation Laboratory HemosIL AcuStar HIT-IgG(PF-4)
The HemoslL AcuStar HIT-lgG(PF-4) may have an invalid calibration curve or negative mean bias with patient samples.
High risk
There is a reasonable chance that using it could cause serious health problems or death.
FDA Class I recall · How risk is rated
What happened
Instrumentation Laboratory recalled 1,414 units of HemoslL AcuStar HIT-lgG(PF-4) (in vitro diagnostic (OUS only)) and 434 units of HemoslL AcuStar HIT-lgG(PF-4) (in vitro diagnostic) on September 3, 2026, due to potential for invalid calibration curve or negative mean bias of up to 47% with patient samples. The FDA classified the recall on October 9, 2026, and added it to the Enforcement Report on October 10, 2026.
Summary by Recall Canary from the FDA notice.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
2 products
Affected if its UDI-DI is listed.
HemoslL AcuStar HIT-lgG(PF-4). Part Number: 0009802028. in vitro diagnostic (OUS only)
- UDI-DI
- 08426950545774
HemoslL AcuStar HIT-lgG(PF-4). Part Number: 0009800127. in vitro diagnostic
- UDI-DI
- 08426951126545
Details
- Company began the recall
- Event ID
- 99843
- Company
- Instrumentation Laboratory
- Hazard
- Device defect
Company began the recall
Classified by FDA
Added to FDA's Enforcement Report
Listed on Recall Canary
