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U.S. Department of Health and Human Services

Class 2 Device Recall Aptima CMV Quant Assay

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  Class 2 Device Recall Aptima CMV Quant Assay see related information
Date Initiated by Firm September 14, 2023
Date Posted March 22, 2024
Recall Status1 Open3, Classified
Recall Number Z-1371-2024
Recall Event ID 94038
Product Classification Cytomegalovirus (cmv) dna quantitative assay - Product Code PAB
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.
Code Information Lot #: 402941/ UDI:15420045514553
Recalling Firm/
Manufacturer		 Hologic, Inc.
10210 Genetic Center Dr
San Diego CA 92121-4362
For Additional Information Contact Sam Im
858-731-5973 Ext. 128
Manufacturer Reason
for Recall		 Use of assay along with plasma specimen may result in error code which would invalidate sample.
FDA Determined
Cause 2		 Use error
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.
Quantity in Commerce 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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