Abbott Diagnostics Technologies AS is recalling five refurbished Afinion 2 (AF2) Analyzers (model #1116986) because they were incorrectly configured for 'Moderate Complexity' testing rather than 'CLIA Waived' status. This error means that laboratories only authorized to perform simple, waived tests might use these machines for more complex assays they are not equipped to manage, which can lead to incorrect medical test results. These five specific units were distributed to customers in Arizona, Indiana, Massachusetts, Minnesota, and Ohio. Consumers and laboratories should contact the manufacturer immediately to ensure their device is properly configured for its intended use.
If a laboratory uses an incorrectly configured analyzer, it may perform diagnostic tests that the facility is not certified to handle, increasing the risk of inaccurate test results that could lead to improper patient diagnosis or treatment.
Manufacturer notification and potential configuration adjustment.
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.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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