Recall Z-1371-2024 ยท PAB Cytomegalovirus (Cmv) Dna Quantitative Assay
Hologic, Inc.
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.
| Date | Mar 22, 2024 (initiated Sep 14, 2023) |
| Status | Open, Classified |
| Reason | Use of assay along with plasma specimen may result in error code which would invalidate sample. |
| 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 t |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.