Device recall
Z-1221-2026: COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an…
FDA device recall · Class II · Beckman Coulter, Inc.
Key facts
| Recall number (Z-number) | Z-1221-2026 |
|---|---|
| Recall event | 97992 |
| Product | COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conjunction with a cyanide-free lytic agent for counting and sizing blood cells on all UniCel DxH Coulter Cellular Analysis Systems. For use as a rinsing agent on the UniCel DxH Slidemaker… |
| Product code | GIF |
| 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