FDA Device recall Z-1084-2026
Asserachrom HPIA. Model/Catalog Number: 00615
- FDA Device
- Class II
- ongoing
- Published 2026-01-21
On 2026-01-21 the FDA classified a Class II recall of Asserachrom HPIA. Model/Catalog Number: 00615 by Diagnostica Stago, citing potential for defect for Asserachrom HPIA lot 271288, which can affect every well in the impacted strip and produce negative results.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1084-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-12-15 |
| Published | 2026-01-21 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Diagnostica Stago |
| Distribution | US |
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
Potential for defect for Asserachrom HPIA lot 271288, which can affect every well in the impacted strip and produce negative results.
Identifiers
| code_info | Reference Number: 00615. UDI: (01)03607450006155(11)240531(17)260531(10)271288(241)00615. Lot Number: 271288. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1084-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.