Device 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.
Z-1371-2024
Product summary
- Firm
- Hologic, Inc.
- Event
- Event 94038
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 684 kits
- Official record key
device-enforcement:Z-1371-2024
Official wording
Reason: Use of assay along with plasma specimen may result in error code which would invalidate sample.
Code information: Lot #: 402941/ UDI:15420045514553
Distribution pattern: 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.
Derived failure modes
-
Unknown
Use of assay along with plasma specimen may result in error code which would invalidate sample.