FDA-Device2025-04-30Class II
The Alinity m System is designed to automate the steps for nucleic acid testing. Model Numbers included in this recall are 08N53-001, 08N53-002, and 08N53-032 (Refurbished).
Abbott Molecular, Inc.
Hazard
The design of the Alinity m System Solutions drawer enclosure may allow liquid (liquid waste or system solutions) originating in the System Solutions drawer to flow beyond the footprint of the instrument and into the walking-path of the user.
Sold states
Worldwide - US Nationwide distribution.
Affected count
N/A
Manufactured in
1300 E Touhy Ave, N/A, Des Plaines, IL, United States
Products
The Alinity m System is designed to automate the steps for nucleic acid testing. Model Numbers included in this recall are 08N53-001, 08N53-002, and 08N53-032 (Refurbished).
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1665-2025Don't want to check this manually?
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