FDA recall Z-1660-2022
Abbott Laboratories · Class II · device
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.
Distribution
Nationwide
Key facts
- Status
- Ongoing
- Initiation date
- 2022-07-26
- Report date
- 2022-09-07
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Abbott Park, IL, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1660-2022