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FDASeptember 14, 2023device

Aptima CMV Quant Assay, Reference numbers: AW-22600-001, AW-25509-001, and AW-26381-001 Amplification Reagent, Enzyme Reagent, Promoter Reagent, Amplification Reconstitution Solution, Enzyme Reconstitution Solution, Promoter Reconstruction solution, Target capture Reagent, Reconstitution Collars.

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

The hazard

Use of assay along with plasma specimen may result in error code which would invalidate sample.

What to do

FDA enforcement status: Ongoing

Brands named

hologic

UPCs

15420045514553

Recall history

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

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