The Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use.
FDA Recall Z-1518-2022 · Posted None
Recalling FirmAbbott Molecular, Inc.
Recall StatusCompleted
Product CodeMZP
Date Initiated2022-07-19
Product Quantity1
Reason for Recall
Incorrect optical calibration
Firm Action
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.
Root Cause
Nonconforming Material/Component
Distribution Pattern
There was only foreign distribution to Italy.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.