Device product

The Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use.

Z-1518-2022

July 19, 2022

Class II

Product summary

Firm: Abbott Molecular, Inc.
Event: Event 90651
Status: Completed
Classification: Class II
Quantity: 1
Official record key: device-enforcement:Z-1518-2022

Official wording

Reason: Incorrect optical calibration

Code information: Serial Number 00654

Distribution pattern: There was only foreign distribution to Italy.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

Incorrect optical calibration