Abbott Molecular, Inc. is recalling 1,012 Alinity m System diagnostic instruments because the system's camera may incorrectly identify sample tubes as being 'capped' when they are not. This error specifically occurs when using certain third-party tubes, such as the Copan UTM-RT 3 mL Without Beads Transport & Preservation Medium (Part Number 3C047N), particularly if the retention bar is missing from the sample rack. The system will then generate an 'Error - 6013: Has cap, no retention bar,' which can disrupt laboratory workflows and potentially delay diagnostic testing results.
If the diagnostic system incorrectly detects a cap on a tube that is actually open, it may stop the testing process or prevent the sample from being processed correctly. This error can lead to significant delays in critical medical diagnoses or laboratory results, which could impact patient care decisions.
Manufacturer communication and operational guidance
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
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Sources: FDA iRES · Raw API Response
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