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Abbott Molecular, Inc. recalls The Alinity m System is designed to automate the steps for nucleic acid testing. Model Numbers included in this recall a
Recalled April 30, 2025 · FDA recall Z-1665-2025 · Abbott Molecular
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. · FDA Class II
Units
N/A
Sold at
Worldwide - US Nationwide distribution.
Description
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.
Product
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).
Manufacturer(s)
Abbott Molecular, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →