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Recall Observatory FDA recall evidence

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

September 14, 2023

Class II

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

    reason.no_named_rule · v1.0.0

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