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Abbott Molecular, Inc. recalls The Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use.
Recalled August 24, 2022 · FDA recall Z-1518-2022 · Abbott Molecular
Hazard
Incorrect optical calibration · FDA Class II
Units
1
Sold at
There was only foreign distribution to Italy.
Description
Incorrect optical calibration
Product
The Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use.
Manufacturer(s)
Abbott Molecular, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →