FDA recall Z-1518-2022
Abbott Molecular, Inc. · Class II · device
Product
The Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use.
Reason for recall
Incorrect optical calibration
Distribution
There was only foreign distribution to Italy.
Key facts
- Status
- Completed
- Initiation date
- 2022-07-19
- Report date
- 2022-08-24
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Des Plaines, IL, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1518-2022