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

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.

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).

An Urgent Field Safety Notice/ Field Correction Recall notification letter was sent to customers. Necessary Actions In accordance with the Alinity m Operations Manual, users should always utilize Personal Protective Equipment when engaging with the instrument. In the event you observe a leak, please take appropriate precautions to prevent exposure and immediately contact your Abbott Molecular Representative for additional troubleshooting information. Please complete and return the associated Customer Reply Form. If you have forwarded this product to any other laboratories, please also forward this letter and customer reply form to that laboratory. Review this information with laboratory personnel and retain this communication for future reference. If you have any questions regarding this communication, please contact your local Abbott representative. We apologize for any inconvenience this may have created for your laboratory.

• FDA enforcement recordOfficial FDA database entry for Z-1665-2025
• FDA device classification · OOIOfficial FDA classification for this device type
• CFR regulation · 21 CFR 862.2570The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Abbott Molecular, Inc.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.