Alinity m System nucleic acid testing instruments recalled for liquid spillage
Abbott Molecular is recalling the Alinity m System due to a design flaw that may allow liquid waste or system solutions to spill beyond the instrument footprint into the user's walking path.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall involving a design defect with potential for liquid spillage. No reported illnesses, injuries, or hospitalizations are stated in the source text, and the hazard is hazard-of-condition (spill risk) rather than contamination or structural failure of a critical nature.
Plain-English summary
Abbott Molecular, Inc. is recalling the Alinity m System, which automates nucleic acid testing steps. The recall affects model numbers 08N53-001, 08N53-002, and 08N53-032 (Refurbished), with worldwide distribution including nationwide US distribution.
The Alinity m System Solutions drawer enclosure has a design flaw that may allow liquid waste or system solutions to flow beyond the instrument footprint and into the walking path of the user. This creates a potential hazard in laboratory and clinical environments where the system is deployed.
Users of affected Alinity m System units should contact Abbott Molecular, Inc. for guidance on remediation or service options. All serial numbers of the affected model numbers are included in this recall.
The recalled product
- Product
- 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).
- Manufacturer
- Abbott Molecular, Inc.
- Hazard
- liquid-spillage
- design-defect
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 (6)
- All Serial Numbers. 08N53-001
- UDI-DI: 00884999047389
- 08N53-002
- UDI-DI: 00884999048034
- 08N53-032
- UDI-DI: 00884999047587
Distribution
Distributed nationwide across the United States.
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