Aptima recallZ-1371-2024 · Hologic, Inc. · initiated Sep 14, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Hologic, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Use of assay along with plasma specimen may result in error code which would invalidate sample.
FDA root cause category: Use error
What the company is doing
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.
Recall details
- Recall number
- Z-1371-2024
- Status
- Open, Classified
- Initiated by the company
- Sep 14, 2023
- Posted by the FDA
- Mar 22, 2024
- Recalling firm
- Hologic, Inc.
- Quantity
- 684 kits
- Product code
- PAB
- 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.
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.
Code information (models, lots, serial numbers)
Lot #: 402941/ UDI:15420045514553
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Aptima® KIT, MAIN ASSAY, CMV, 100-TEST, IVDHologic, Inc. · Cytomegalovirus (cmv) dna quantitative assay1 recall2 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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