Z-1371-2024 Class II Ongoing
FDA device recall Z-1371-2024 was initiated by Hologic, Inc. on September 14, 2023 and is designated Class II. Reason for recall: Use of assay along with plasma specimen may result in error code which would invalidate sample. The recall status is ongoing. Affected quantity: 684 kits.
Recall Details
- Product Type
- Devices
- Report Date
- April 3, 2024
- Initiation Date
- September 14, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 684 kits
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.
Reason for Recall
Use of assay along with plasma specimen may result in error code which would invalidate sample.
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.
Code Information
Lot #: 402941/ UDI:15420045514553