Alinity m recallZ-1665-2025 · Abbott Molecular, Inc. · initiated Mar 20, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Abbott Molecular, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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.
FDA root cause category: Device Design
What the company is doing
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.
Recall details
- Recall number
- Z-1665-2025
- Status
- Open, Classified
- Initiated by the company
- Mar 20, 2025
- Posted by the FDA
- Apr 24, 2025
- Recalling firm
- Abbott Molecular, Inc.
- Product code
- OOI
- Distribution
- Worldwide - US Nationwide distribution.
Product description
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).
Code information (models, lots, serial numbers)
All Serial Numbers. 08N53-001, UDI-DI: 00884999047389; 08N53-002, UDI-DI: 00884999048034; 08N53-032, UDI-DI: 00884999047587
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Alinity m 08N53-002Abbott Molecular Inc. · real time Nucleic acid amplification system4 recalls950 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page