Asserachrom HPIA — Class II medical device recall Z-1084-2026
Ongoing recall by Diagnostica Stago, Inc., reported 2026-01-21, distributed nationwide. Potential for defect for Asserachrom HPIA lot 271288, which can affect every well in the impacted strip and pr
| Recall number | Z-1084-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Diagnostica Stago, Inc., Parsippany, NJ, United States |
| Recall initiated | 2025-12-15 |
| Classified | 2026-01-14 |
| Reported by FDA | 2026-01-21 |
| Distributed | Nationwide (US) |
| Countries outside the US | BE, CA, DK, DZ, ES, FI, FR, GB, IT, LB, SA |
| Quantity | 438 units |
| UPC / GTIN / UDI-DI | 03607450006155 |
| Lot numbers | 271288 |
| Model numbers | 00615 |
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 for recall
Potential for defect for Asserachrom HPIA lot 271288, which can affect every well in the impacted strip and produce negative results.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1084-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.