Reported Oct 21, 2026 · Ongoing · Updated Oct 26, 2026
HemoslL AcuStar HIT-lgG(PF-4). Part Number: 0009802028. in vitro diagnostic (OUS only)
Instrumentation Laboratory
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Instrumentation Laboratory · 180 Hartwell Rd · Bedford, MA · 01730-2443
Is this the product you have?
- HemoslL AcuStar HIT-lgG(PF-4)
- Part Number0009802028. in vitro diagnostic (OUS only)
- Lot codes and dates
- Part Number0009802028
- UDI-DI08426950545774
- Lot Number (Expiration Date)
B40006 (01/16/2027)B38063 (11/01/2026)
- Amount recalled
- 1,414 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Stop using this product now
Potential for invalid calibration curve or negative mean bias of up to 47% with patient samples.
Using this product could cause serious injury, illness or death — stop using it now.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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