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.
Other recalls by Abbott Laboratories
- Alinity ci-series System Control Module (SCM), REF: 03R70-01, 03R70-20
FDA Device · Class II · 2025-12-24 · Abbott Laboratories - Brand Name: Alinity hq Analyzer Product Name: Alinity hq Analyzer Model/Catalog Number: 09P68-01 Software Version: 5.0 to 5.10.1 for OUS, 5…
FDA Device · Class II · 2025-11-19 · Abbott Laboratories - Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-13 Software Version: All software versions Product Descri…
FDA Device · Class II · 2025-04-30 · Abbott Laboratories - Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-01 Software Version: All software versions Product Descri…
FDA Device · Class II · 2025-04-30 · Abbott Laboratories - Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-10 Software Version: All software versions Product Descri…
FDA Device · Class II · 2025-04-30 · Abbott Laboratories
All Abbott Laboratories recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1660-2022%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.