FDA Device recall Z-1660-2022
ARCHITECT STAT Troponin-I Reagent Kit, REF 2K41-27
- FDA Device
- Class II
- ongoing
- Published 2022-09-07
On 2022-09-07 the FDA classified a Class II recall of ARCHITECT STAT Troponin-I Reagent Kit, REF 2K41-27 by Abbott Laboratories, citing one lot of reagent was manufactured with insufficient quantities of the heterophilic blocking agents in the conjugate component.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1660-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-07-26 |
| Published | 2022-09-07 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Abbott Laboratories |
| Distribution | US |
Product
ARCHITECT STAT Troponin-I Reagent Kit, REF 2K41-27
Reason
One lot of reagent was manufactured with insufficient quantities of the heterophilic blocking agents in the conjugate component.
Identifiers
| code_info | UDI (01) 00380740048525 (17) 991231 (10) 12345M100 (240) 2K4127 Lot lot 63718UN22 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1660-2022%22
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