Device recall
Z-0354-2019: Software Package, Sorting-Drive 4.2 User Kit, Part No. B73488, Manufactured by…
FDA device recall · Class III · Beckman Coulter Inc.
Key facts
| Recall number (Z-number) | Z-0354-2019 |
|---|---|
| Recall event | 80434 |
| Product | Software Package, Sorting-Drive 4.2 User Kit, Part No. B73488, Manufactured by: Beckman Coulter Biomedical GmbH The Sorting-Drive itself is an optional software to be used with the Automate 2500 Family of products. The system automates the process of sorting, decapping, and archiving samples. The… |
| Product code | JQP |
| Recalling firm | Beckman Coulter Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Dec 8, 2022 |
| FEI number | 2050012 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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