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FDAJune 17, 2024device

Afinion 2 Analyzer, model #1116986, US refurbished, CLIA waived.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Ongoing

Brands named

abbott diagnostics technologies asabbottabbott diagnostics

UPCs

07070060014708

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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