FDA DevicesClass II
Asserachrom HPIA. Model/Catalog Number: 00615. The Asserachrom HPIA kit is ...
Published: January 21, 2026Recall ID: Z-1084-2026Category: devicesCountry: US
Reason for Recall / Hazard
Potential for defect for Asserachrom HPIA lot 271288, which can affect every well in the impacted strip and produce negative results.
Product Description & Identification
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.
Affected Products
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.
Additional Source Details
| Field | Value |
|---|---|
| City | Parsippany |
| State | NJ |
| Event id | 98163 |
| Address 1 | 5 Century Dr |
| Code info | Reference Number: 00615. UDI: (01)03607450006155(11)240531(17)260531(10)271288(241)00615. Lot Number: 271288. |
| Postal code | 07054-4607 |
| Report date | 20260121 |
| Product type | Devices |
| 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. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20251215 |
| Initial firm notification | |
| Center classification date | 20260114 |
Overview
- Recalling FirmDiagnostica Stago, Inc.
- StatusOngoing
- Risk LevelClass II
- DistributionWorldwide - 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.