Device recall
Z-0093-2025: Beckman Coulter IRISPEC CA/CB/CC Urine Chemistry Controls, Catalog Number REF…
FDA device recall · Class III · Beckman Coulter, Inc.
Key facts
| Recall number (Z-number) | Z-0093-2025 |
|---|---|
| Recall event | 95159 |
| Product | Beckman Coulter IRISPEC CA/CB/CC Urine Chemistry Controls, Catalog Number REF 800-7211 and 800-7702, in vitro diagnostic device. |
| Product code | JJW |
| Recalling firm | Beckman Coulter, Inc. |
| Recall class | Class III |
| Status | Open, Classified |
| 510(k) numbers | K072640 |
| FEI number | 3000203293 |
At a glance
- 1–9 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