Abbott Molecular, Inc. recalls The Alinity m System is designed to automate the steps for nucleic acid testing. Model Numbers included in this recall…

Recall date

March 20, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1665-2025

FDA classification

Class II

Brand / firm

Abbott Molecular, Inc.

Sold / distributed

Worldwide - US Nationwide distribution.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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).