FDAFDA · Food and drugs·Recall number Z-1371-2024
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.
Published April 3, 2024 · Recall initiated: September 14, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Use of assay along with plasma specimen may result in error code which would invalidate sample.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Hologic, Inc.
- Distributor
- Worldwide - US Nationwide distribution in the states of CA, CT, FL, ID, IL, MD, MI, MO, TN, TX, WI and the countries of Australia, Germany, Denmark, Spain, France, Great Britain, Italy, Norway, Qatar, Sweden.
- Lot
- Lot #: 402941/ UDI:15420045514553
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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