Z-1665-2025Class II

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

Name: Z-1665-2025 The Alinity m System is designed to automate the steps for nucleic acid testing. Model Numbers included in...
Creator: Abbott Molecular, Inc.
Published: 2025-03-20
License: https://open.fda.gov/license/

Abbott Molecular, Inc. / initiated 2025-03-20 / Open, Classified / root cause: design

FDA source

Abbott Molecular, Inc. began a recall of 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... on 2025-03-20. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-1665-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-03-20
Posted: 2025-04-24
Recalling firm: Abbott Molecular, Inc.
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).
Product code: OOI Real Time Nucleic Acid Amplification System
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.
Root cause tag: design
FDA root cause: Device Design
Action: 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.
Distribution: Worldwide - US Nationwide distribution.
Product codes and lots: All Serial Numbers. 08N53-001, UDI-DI: 00884999047389; 08N53-002, UDI-DI: 00884999048034; 08N53-032, UDI-DI: 00884999047587

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1665-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1665-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-04-30	2025-04-24

Product code OOI

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)