Device recall
Z-0412-2026: CellMek SPS Sample Preparation System, REF: C44603. Software versions 2.2.122.0…
FDA device recall · Class II · Beckman Coulter, Inc.
Key facts
| Recall number (Z-number) | Z-0412-2026 |
|---|---|
| Recall event | 97531 |
| Product | CellMek SPS Sample Preparation System, REF: C44603. Software versions 2.2.122.0 and prior, and Instructions for Use (IFU) revisions AD and prior. These CellMek devices include Cassette E. |
| Product code | PER |
| Recalling firm | Beckman Coulter, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| FEI number | 3000203293 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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