Diagnostica Stago Asserachrom HPIA lot 271288 recalled for defective test wells
Diagnostica Stago is recalling lot 271288 of the Asserachrom HPIA test kit, which detects antibodies related to heparin-induced thrombocytopenia (HIT type II). The affected lot may have defective test wells that produce false negative results, meaning the test could fail to detect the condition when it is present.
From the FDA notice · Read the official notice ↗ · All Diagnostica Stago recalls
What to do
- Check if you have Asserachrom HPIA lot 271288 (look for lot number on the package)
- Stop using this lot immediately
- Contact Diagnostica Stago or your distributor for instructions on returning or replacing the product
- If tests were run on this lot, consider retesting patients with an alternative method
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- Asserachrom HPIA. Model/Catalog Number: 00615. 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.
- Sold in
- Nationwide
- Made for
- All ages (under 100 years)
Details
- Units affected
- 438 units
- Illnesses reported
- None reported
- Manufactured in
- 5 Century Dr, Parsippany, NJ, United States
- Classification
- Class II
- Recall number
- Z-1084-2026
In the FDA's words
- Description
- Asserachrom HPIA. Model/Catalog Number: 00615. 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. Potential for defect for Asserachrom HPIA lot 271288, which can affect every well in the impacted strip and produce negative results. Reference Number: 00615. UDI: (01)03607450006155(11)240531(17)260531(10)271288(241)00615. Lot Number: 271288. Distribution: Worldwide - US Nationwide distribution in the states of AL, CA, FL, GA, HI, IA, MA, MI, NJ, NV, NY, OH, TN, WI and the countries of Belgium, Canada, Denmark, Algeria, Spain, Finland, France, Great Britain, Italy, Lebanon, Saudi Arabia, Uganda. Affected quantity: 438 units
- Hazard
- Potential for defect for Asserachrom HPIA lot 271288, which can affect every well in the impacted strip and produce negative results.
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ModerateFDASep 9, 2026