Reported Apr 3, 2024 · Ongoing
Aptima CMV Quant Assay, Reference numbers: AW-22600-001, AW-25509-001, and AW-26381-001 Amplification Reagent, Enzyme…
Hologic, Inc.
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: Hologic, Inc. · 10210 Genetic Center Dr · San Diego, CA · 92121-4362
Is this the product you have?
- Aptima CMV Quant Assay
- Reference numbersAW-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
- Lot codes and dates
- Lot #: 402941/
- UDI15420045514553
- Amount recalled
- 684 kits
Where it was sold
Why it was recalled
Use of assay along with plasma specimen may result in error code which would invalidate sample.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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