Z-1518-2022 Class II
FDA device recall Z-1518-2022 was initiated by Abbott Molecular, Inc. on July 19, 2022 and is designated Class II. Reason for recall: Incorrect optical calibration Affected quantity: 1.
Recall Details
- Product Type
- Devices
- Report Date
- August 24, 2022
- Initiation Date
- July 19, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1
Product Description
The Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use.
Reason for Recall
Incorrect optical calibration
Distribution Pattern
There was only foreign distribution to Italy.
Code Information
Serial Number 00654