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

FDA device recall Z-1371-2024 · posted 2024-03-22 · Open, Classified

Recall details

Recalling firm

Hologic, Inc.

Reason for recall

Use of assay along with plasma specimen may result in error code which would invalidate sample.

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.

Root cause

Use error

Status

Open, Classified

Product code

PAB

Quantity affected

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,

Date initiated

2023-09-14

Date posted

2024-03-22

Location

San Diego, CA