Recall Z-1665-2025— Abbott Molecular, Inc.
Class II · Ongoing
Class II FDA medical device recall by Abbott Molecular, Inc., initiated 2025-03-20. FDA's recall record names no specific 510(k) clearance for this event. 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).. 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..
- Recalling firm
- Abbott Molecular, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-03-20
- Firm location
- Des Plaines, IL, United States
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).
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.