Drug recall
Reagent Red Blood Cells
FDA recall event 92947 · Class II · Immucor, Inc.
Key facts
| Event ID | 92947 |
|---|---|
| Recall numbers | B-0635-2023 |
| Recalling firm | Immucor, Inc. |
| Product type | Biologics |
| Products | Reagent Red Blood Cells |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Donor A5165 (Di(a+) Cell, lot 06439) is listed as Di(a+) on the master list, but is resulting as Di(a-) with multiple sources of Anti-Dia. Since the reactivity of the Dia antigen has diminished, the… |
| Initiation date | Apr 3, 2023 |
| Report date | Oct 25, 2023 |
| Termination date | Jan 10, 2024 |
| City | Norcross |
| State | GA |
| Country | United States |
| FEI number | 1034569 |
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: