FDA Enforcement
Class II
Ongoing
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.
Recall: Z-1371-2024
·
Reported April 3, 2024
Enforcement
- Recall Number
- Z-1371-2024
- Event ID
- 94038
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Hologic, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- April 3, 2024
- Initiation Date
- September 14, 2023
- Classification Date
- March 22, 2024
- Address
- 10210 Genetic Center Dr, N/A, San Diego, CA, 92121-4362, United States
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
Use of assay along with plasma specimen may result in error code which would invalidate sample.
Code Info
Lot #: 402941/ UDI:15420045514553
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