Hologic, Inc.: 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, E

Hazard

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

Details from the source

Reason for recall: Use of assay along with plasma specimen may result in error code which would invalidate sample. Distribution: 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. Quantity: 684 kits Lot/code info: Lot #: 402941/ UDI:15420045514553

UPC codes

15420045514553

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.