Class II — Abbott Laboratories
| Recalling firm | ABBOTT LABORATORIES |
|---|---|
| Registered facility | View this company's 64 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | One lot of reagent was manufactured with insufficient quantities of the heterophilic blocking agents in the conjugate component. |
| Product | ARCHITECT STAT Troponin-I Reagent Kit, REF 2K41-27 |
| Quantity | 2451 kits of 100 tests |
| Distribution | Nationwide |
| Initiated | 2022-07-26 |
| Classified | 2022-08-30 |
| Recall number | Z-1660-2022 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Abbott Laboratories (Z-1660-2022).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/90692/
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