ARCHITECT STAT Troponin-I Reagent Kit — Class II medical device recall Z-1660-2022
Ongoing recall by Abbott Laboratories, reported 2022-09-07, distributed nationwide. One lot of reagent was manufactured with insufficient quantities of the heterophilic blocking agents in the co
| Recall number | Z-1660-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Abbott Laboratories, Abbott Park, IL, United States |
| Recall initiated | 2022-07-26 |
| Classified | 2022-08-30 |
| Reported by FDA | 2022-09-07 |
| Distributed | Nationwide (US) |
| UPC / GTIN / UDI-DI | 00380740048525 |
| Lot numbers | 63718UN22 |
| Model numbers | 2K41-27 |
Product
ARCHITECT STAT Troponin-I Reagent Kit, REF 2K41-27
Reason for recall
One lot of reagent was manufactured with insufficient quantities of the heterophilic blocking agents in the conjugate component.
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-1660-2022. 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.