Device recall
Z-2231-2011: COULTER Ac"T" 5diff Fix Reagent. Part Number: 8547171 COULTER AC"T" 5diff Fix…
FDA device recall · Class II · Beckman Coulter Inc.
Key facts
| Recall number (Z-number) | Z-2231-2011 |
|---|---|
| Recall event | 58569 |
| Product | COULTER Ac"T" 5diff Fix Reagent. Part Number: 8547171 COULTER AC"T" 5diff Fix, Instructions for Use, PN 772264. Intended for use as a leukocyte reagent to differentiate subpopulations of cells on COULTER Ac"T 5diff hematology analyzers. Intended for use only with specific Ac"T 5diff reagents. Refer… |
| Product code | GGK |
| Recalling firm | Beckman Coulter Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 4, 2012 |
| FEI number | 2050012 |
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