Diagnostica Stago, Inc.: Device Recall
Recall #Z-1084-2026 · 12/15/2025
Class II: Risk
Recall Details
- Recall Number
- Z-1084-2026
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Diagnostica Stago, Inc.
- Status
- Ongoing
- Date Initiated
- 12/15/2025
- Location
- Parsippany, NJ, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 438 units
Reason for Recall
Potential for defect for Asserachrom HPIA lot 271288, which can affect every well in the impacted strip and produce negative results.
Product 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.
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.
Other Recalls by Diagnostica Stago, Inc.
- Class II: Risk 09/12/2025
- Class II: Risk 07/21/2025
- Class II: Risk 07/21/2025
- Class II: Risk 07/21/2025
- Class II: Risk 07/21/2025
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.