Abbott Alinity m System camera generates error with certain tubes
Abbott Molecular is recalling 1,012 Alinity m System units due to a camera detection issue that generates an error message when certain third-party transport medium tubes lack a sample rack retention bar.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device recall with an observed functional issue where the system generates error messages with certain third-party tubes. No reported illnesses, injuries, or hospitalizations are documented, limiting the score to a maximum of 3 per the established rubric.
Plain-English summary
The Alinity m System is a molecular diagnostic device manufactured by Abbott Molecular, Inc. The system's camera detects whether sample tubes are capped. An issue has been identified where the camera may detect a cap on a tube without a retention bar present on the sample rack, causing the system to generate an 'Error - 6013: Has cap, no retention bar' message.
The issue has been specifically observed with Copan UTM-RT 3 mL Without Beads Transport & Preservation Medium for Viral Molecular Diagnostics Testing (Part Number 3C047N) when used with the Alinity m System. Abbott has indicated that other third-party manufactured tubes could potentially experience the same issue.
Approximately 1,012 units of the Alinity m System (Part Number 08N53-002) have been identified in this recall and distributed worldwide. Abbott Molecular, Inc. is recalling these units to address the camera detection and error message generation issue.
The recalled product
- Product
- Alinity m System, Part Number: 08N53-002
- Manufacturer
- Abbott Molecular, Inc.
- Category
- Medical Device
- Hazard
- system-error
- tube-incompatibility
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Part Number: 08N53-002
- UD/DI: 00884999048034. Not Serial Number specific
Distribution
Distributed nationwide across the United States.
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