Recall Z-1665-2025 ยท OOI Real Time Nucleic Acid Amplification System
Abbott Molecular, Inc.
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).
| Date | Apr 24, 2025 (initiated Mar 20, 2025) |
| Status | Open, Classified |
| Reason | 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 | 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 forwar |
| Distribution | Worldwide - US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.