Device 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.
Z-1084-2026
Product summary
- Event
- Event 98163
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 438 units
- Official record key
device-enforcement:Z-1084-2026
Official wording
Reason: Potential for defect for Asserachrom HPIA lot 271288, which can affect every well in the impacted strip and produce negative results.
Code information: Reference Number: 00615. UDI: (01)03607450006155(11)240531(17)260531(10)271288(241)00615. Lot Number: 271288.
Distribution pattern: 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.
Derived failure modes
-
Unknown
Potential for defect for Asserachrom HPIA lot 271288, which can affect every well in the impacted strip and produce negative results.