Reported May 1, 2024 · Ongoing
Alinity m System, Part Number: 08N53-002
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?
- Alinity m System
- Part Number08N53-002
- Lot codes and dates
- Part Number08N53-002
- UD/DI00884999048034. Not Serial Number specific
- Amount recalled
- 1,012 units
Where it was sold
- Nationwide
Why it was recalled
The Alinity m System camera detects whether tubes are "capped." If the camera detects a cap and the retention bar is not present on the sample rack, the system will generate the message 'Error - 6013: Has cap, no retention bar." Abbott has identified an issue concerning the use of certain third-party Universal Transport Medium (UTM) tubes on the Alinity m System. This issue has been observed with Copan UTM-RT 3 mL Without Beads Transport & Preservation Medium for Viral Molecular Diagnostics Testing, Part Number (PN) 3C047N. However, it is possible that other third party manufactured tubes could experience the same issue.
This product could cause temporary or reversible health problems — stop using it.
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