Lab analyzer incorrectly configured for complex testing at waived facilities
Five Afinion 2 lab analyzers were distributed with incorrect configuration, potentially allowing waived laboratories to perform moderately complex assays that could produce erroneous results.
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: This is a risk-of-harm medical device where incorrect configuration could allow unauthorized complex testing in waived labs, potentially producing diagnostic errors. No illnesses or injuries have been reported; per the rubric, risk-of-harm products without reported injury score at most 3 (High).
Plain-English summary
Abbott Diagnostics Technologies AS is recalling five Afinion 2 Analyzer units (model #1116986) that were incorrectly configured as Moderate Complexity devices.
The affected analyzers were distributed to customers in Arizona, Indiana, Massachusetts, Minnesota, and Ohio. The incorrect configuration allows moderately complex assays to be performed in Clinical Laboratory Improvement Amendments (CLIA) waived laboratories, which are not authorized to perform such assays. This could result in erroneous test results.
No illnesses or injuries have been reported. Owners of the affected units should contact Abbott Diagnostics Technologies AS or the FDA for guidance on their specific analyzer.
The recalled product
- Product
- Afinion 2 Analyzer, model #1116986, US refurbished, CLIA waived.
- Manufacturer
- Abbott Diagnostics Technologies AS
- Hazard
- diagnostic-error
- mis-configuration
- erroneous-results
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)
- Lot #433706
- Serial numbers AF20008880
- AF20002691
- AF20035414
- AF20015543 and AF20035460
- UDI-DI: 07070060014708.
Distribution
Distributed nationwide across the United States.
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