medical MODERATE Updated 2024-04-03

Hologic, Inc. recalls Aptima CMV Quant Assay, Reference numbers: AW-22600-001, AW-

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Recalled Product

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.

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Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot #: 402941/ UDI:15420045514553

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.

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View official government recall