The Alinity m System is designed to automate the steps for nucleic acid testing. Model Numbers included in this recall a

FDA device recall Z-1665-2025 · posted 2025-04-24 · Open, Classified

Recall details

Recalling firm

Abbott Molecular, Inc.

Reason for recall

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.

Action taken

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.

Root cause

Device Design

Status

Open, Classified

Product code

OOI

Distribution

Worldwide - US Nationwide distribution.

Date initiated

2025-03-20

Date posted

2025-04-24

Location

Des Plaines, IL