Reported Sep 4, 2024 · Ongoing
Afinion 2 Analyzer, model #1116986, US refurbished, CLIA waived.
Abbott Diagnostics Technologies AS
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Abbott Diagnostics Technologies AS · Kjelsasveien 161 · Oslo · N/A
Is this the product you have?
- Afinion 2 Analyzer, model #1116986, US refurbished, CLIA waived.
- Lot codes and dates
Lot #433706Serial numbers AF20008880AF20002691AF20035414AF20015543 and AF20035460
- UDI-DI07070060014708
- Amount recalled
- 5 analyzers
Where it was sold
Why it was recalled
Five Afinion 2 (AF2) Analyzer were incorrectly market configured as Moderate Complexity and distributed to customers. Use of moderately complex assays by waived laboratories could result in erroneous results.
This product could cause temporary or reversible health problems — stop using it.
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