FDA-Device2022-08-24Class II
The Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use.
Abbott Molecular, Inc.
Hazard
Incorrect optical calibration
Sold states
There was only foreign distribution to Italy.
Affected count
1
Manufactured in
1300 E Touhy Ave, Des Plaines, IL, United States
Products
The Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1518-2022Don't want to check this manually?
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