Aptima CMV Quant Assay — Class II medical device recall Z-1371-2024
Ongoing recall by Hologic, Inc., reported 2024-04-03, distributed nationwide. Use of assay along with plasma specimen may result in error code which would invalidate sample.
| Recall number | Z-1371-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hologic, Inc., San Diego, CA, United States |
| Recall initiated | 2023-09-14 |
| Classified | 2024-03-22 |
| Reported by FDA | 2024-04-03 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, DE, DK, ES, FR, GB, IT, NO, QA, SE |
| Quantity | 684 kits |
| Reason classes | potency |
| UPC / GTIN / UDI-DI | 15420045514553 |
| Lot numbers | 402941 |
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.
Reason for recall
Use of assay along with plasma specimen may result in error code which would invalidate sample.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1371-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.