Recall Z-1371-2024
Hologic, Inc. · initiated September 14, 2023
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: Lot #: 402941/ UDI:15420045514553
Reason for recall
Use of assay along with plasma specimen may result in error code which would invalidate sample.
FDA-determined cause: Use error
Action taken
On February 23, 2024, Hologic issued a "Urgent Medical Device Recall Update" via FedEx. The update notified consignees of a sample dilution workflow for specific plasma specimens. On September 14, 2023 Hologic issued a "Urgent Medical Device Recall Notification" to affected consignees, via Fed Ex. Hologic provided the following information to customers: 1. Continue to use the Aptima CMV Quant assay. 2.When obtaining an ML2 error, please run the Mag Wash Clean Procedure and Contact Hologic Technical Support 3. With the Aptima CMV Quant assay, it is not recommended to retest a sample that was previously invalidated due to an ML2 error on the Panther instrument. 4. Complete Customer Response Form On (date) the firm issued a Customer Technical Bulletin, to consignees describing a sample dilution workflow for plasma specimens.
Details
- Recall number
- Z-1371-2024
- Initiated
- September 14, 2023
- Posted by FDA
- March 22, 2024
- Product code
- PAB – Cytomegalovirus (Cmv) Dna Quantitative Assay
- Quantity
- 684 kits
- 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.
- Recalling firm
- Hologic, Inc., San Diego, CA