Drug recall
UniCel DxH 600 Coulter Cellular Analysis System, Catalog No. B23858.
FDA recall event 77145 · Class II · Beckman Coulter Inc.
Key facts
| Event ID | 77145 |
|---|---|
| Recall numbers | Z-2157-2017, Z-2158-2017 |
| Recalling firm | Beckman Coulter Inc. |
| Product type | Devices |
| Products | UniCel DxH 600 Coulter Cellular Analysis System, Catalog No. B23858., UniCel DxH 800 Coulter Cellular Analysis System, Catalog No. 629029, B24465, B24802, B66445, B68304, B63322. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | There is a possibility of a data acquisition disruption that may cause an unusual light scatter event pattern for the white blood cell differential that may not have a system flag and/or message. The… |
| Initiation date | Apr 24, 2017 |
| Report date | May 31, 2017 |
| Termination date | May 22, 2018 |
| City | Brea |
| State | CA |
| Country | United States |
| FEI number | 2050012 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: