Drug recall
ARCHITECT STAT Troponin-I Reagent Kit, REF 2K41-27
FDA recall event 90692 · Class II · Abbott Laboratories
Key facts
| Event ID | 90692 |
|---|---|
| Recall numbers | Z-1660-2022 |
| Recalling firm | Abbott Laboratories |
| Product type | Devices |
| Products | ARCHITECT STAT Troponin-I Reagent Kit, REF 2K41-27 |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | One lot of reagent was manufactured with insufficient quantities of the heterophilic blocking agents in the conjugate component. |
| Initiation date | Jul 26, 2022 |
| Report date | Sep 7, 2022 |
| City | Abbott Park |
| State | IL |
| Country | United States |
| FEI number | 1415939 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: