The Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use.
This recall has been completed (originally issued July 19, 2022).
- Company
- Abbott Molecular, Inc.
- Recall Initiated
- July 19, 2022
- Recall Number
- Z-1518-2022
- Quantity
- 1
- Firm Location
- Des Plaines, IL
- Official Source
- View on FDA website ↗
Reason for Recall
Incorrect optical calibration
Distribution
There was only foreign distribution to Italy.
Lot / Code Info
Serial Number 00654
Root Cause
Nonconforming Material/Component
Action Taken
The recalling firm issued a letter dated 7/19/2022 via Abbott representative delivery on 7/19/2022 confirming the issue the customer had with their instrument. The letter also said the impacted ADU4 module was taken out of service on 1/25/2022 and was then replaced with a new module on 3/22/2022. The letter discussed the potential impact and the necessary actions to take which included completing and returning the Customer Reply Form and reviewing this information with laboratory personnel and retain the communication for future reference.