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Hologic, Inc. recalls Aptima CMV Quant Assay, Reference numbers: AW-22600-001, AW-25509-001, and AW-26381-001 Amplification Reagent, Enzyme Re
Recalled April 3, 2024 · FDA recall Z-1371-2024 · Hologic
Hazard
Use of assay along with plasma specimen may result in error code which would invalidate sample. · FDA Class II
Units
684 kits
Sold at
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.
Description
Use of assay along with plasma specimen may result in error code which would invalidate sample.
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.
Manufacturer(s)
Hologic, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →