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Recall Observatory FDA recall evidence

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

December 15, 2025

Class II

Product summary

Firm
Diagnostica Stago, Inc.
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

    reason.no_named_rule · v1.0.0

    Potential for defect for Asserachrom HPIA lot 271288, which can affect every well in the impacted strip and produce negative results.