Reported Jan 21, 2026 · Ongoing
Asserachrom HPIA. Model/Catalog Number: 00615. The Asserachrom HPIA kit is intended for the qualitative detection in…
Diagnostica Stago, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.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: Diagnostica Stago, Inc. · 5 Century Dr · Parsippany, NJ · 07054-4607
Is this the product you have?
- Asserachrom HPIA
- Model/Catalog Number00615. The Asserachrom HPIA kit is intended for the qualitative detection in plasma or serum of the anti-heparin-platelet factor 4 (PF4) antibodies generated during the type II heparin-induced thrombocytopenia (HIT type II) by ELISA
- Lot codes and dates
- Reference Number00615
- UDI(01)03607450006155(11)240531(17)260531(10)271288(241)00615
- Lot Number271288
- Amount recalled
- 438 units
Where it was sold
Why it was recalled
Potential for defect for Asserachrom HPIA lot 271288, which can affect every well in the impacted strip and produce negative results.
This product could cause temporary or reversible health problems — stop using it.
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