Diagnostica Stago, Inc.: Asserachrom HPIA. Model/Catalog Number: 00615. The Asserachrom HPIA kit is intended for the qualitative detection in plasma or serum of
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- Company / brand
- Diagnostica Stago, Inc.
- 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.
- Reason / hazard
- Potential for defect for Asserachrom HPIA lot 271288, which can affect every well in the impacted strip and produce negative results.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- 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.
- Recall initiated
- 2025-12-15
- Code info
- Reference Number: 00615. UDI: (01)03607450006155(11)240531(17)260531(10)271288(241)00615. Lot Number: 271288.
- Product quantity
- 438 units
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Parsippany
- State
- NJ
- Country
- United States
- Event id
- 98163
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