Z-1371-2024Class II

Aptima CMV Quant Assay, Reference numbers: AW-22600-001, AW-25509-001, and AW-26381-001 Amplification...

Name: Z-1371-2024 Aptima CMV Quant Assay, Reference numbers: AW-22600-001, AW-25509-001, and AW-26381-001 Amplification...
Creator: Hologic, Inc.
Published: 2023-09-14
License: https://open.fda.gov/license/

Hologic, Inc. / initiated 2023-09-14 / Open, Classified

FDA source

Hologic, Inc. began a recall of Aptima CMV Quant Assay, Reference numbers: AW-22600-001, AW-25509-001, and AW-26381-001 Amplification Reagent, Enzyme Reagent, Promoter Reagent, Amplification... on 2023-09-14. FDA classified it as Class II and gives the reason as "Use of assay along with plasma specimen may result in error code which would invalidate sample". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1371-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-09-14
Posted: 2024-03-22
Recalling firm: Hologic, Inc.
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.
Product code: PAB Cytomegalovirus (Cmv) Dna Quantitative Assay
Reason for recall: Use of assay along with plasma specimen may result in error code which would invalidate sample.
FDA root cause: 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.
Product codes and lots: Lot #: 402941/ UDI:15420045514553

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1371-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1371-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-04-03	2024-03-22

Product code PAB

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)