Reported Apr 30, 2025 · Ongoing
The Alinity m System is designed to automate the steps for nucleic acid testing. Model Numbers included in this recall…
Abbott Molecular, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Abbott Molecular, Inc. · 1300 E Touhy Ave · Des Plaines, IL · 60018-3315
Is this the product you have?
- 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).
- Lot codes and dates
- All Serial Numbers. 08N53-001
- UDI-DI
0088499904738908N53-002
- UDI-DI
0088499904803408N53-032
- UDI-DI00884999047587
- Amount recalled
- N/A
Where it was sold
- Nationwide
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.
This product could cause temporary or reversible health problems — stop using it.
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