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.
FDA Recall Z-1371-2024 · Posted 2024-03-22
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Recalling FirmHologic, Inc.
Recall StatusOpen, Classified
Product CodePAB
Date Initiated2023-09-14
Product Quantity684 kits
Reason for Recall
Use of assay along with plasma specimen may result in error code which would invalidate sample.
Firm Action
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.
Root Cause
Use error
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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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