Hologic, Inc.: Medical Device Recall in 2024 - (Recall #: Z-1371-2024)
See the recall detail below. You can also see other recalls from the same firm in 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.
Class II
Use of assay along with plasma specimen may result in error code which would invalidate sample.
Lot #: 402941/ UDI:15420045514553
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.
Voluntary: Firm initiated