Hologic, Inc.: Medical Device Recall in 2024 - (Recall #: Z-1371-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.
Product Description:

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.

Product Classification:

Class II

Date Initiated: September 14, 2023
Date Posted: April 3, 2024
Recall Number: Z-1371-2024
Event ID: 94038
Reason for Recall:

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

Status: Ongoing
Product Quantity: 684 kits
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.

Voluntary or Mandated:

Voluntary: Firm initiated