Drug recall
LeukoSure Enumeration Kit, Catalog No. 175621, UDI 15099590538088
FDA recall event 91218 · Class II · Beckman Coulter Inc.
Key facts
| Event ID | 91218 |
|---|---|
| Recall numbers | B-0337-2023 |
| Recalling firm | Beckman Coulter Inc. |
| Product type | Biologics |
| Products | LeukoSure Enumeration Kit, Catalog No. 175621, UDI 15099590538088 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Beckman Coulter is recalling distributed units of LeukoSure Enumeration Kits because the kits may not be able to acquire 10,000 LeukoSure Fluorosphere events within 300 seconds due to inadequate… |
| Initiation date | Nov 22, 2022 |
| Report date | Apr 19, 2023 |
| Termination date | Dec 12, 2024 |
| 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: