FDAFDA · Food and drugs·Recall number Z-1665-2025
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).
Published April 30, 2025 · Recall initiated: March 20, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Abbott Molecular, Inc.
- Distributor
- Worldwide - US Nationwide distribution.
- Lot
- All Serial Numbers. 08N53-001, UDI-DI: 00884999047389; 08N53-002, UDI-DI: 00884999048034; 08N53-032, UDI-DI: 00884999047587
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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