Device recall
Z-1371-2024: Aptima CMV Quant Assay, Reference numbers: AW-22600-001, AW-25509-001, and…
FDA device recall · Class II · Hologic, Inc.
Key facts
| Recall number (Z-number) | Z-1371-2024 |
|---|---|
| Recall event | 94038 |
| 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 |
| Recalling firm | Hologic, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| FEI number | 2024800 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database