Drug recall
AbSorber XM-ONE Transplantation Cross Match, ABX100-03
FDA recall event 68782 · Class III · Olerup SSP AB
Key facts
| Event ID | 68782 |
|---|---|
| Recall numbers | B-0836-14 |
| Recalling firm | Olerup SSP AB |
| Product type | Biologics |
| Products | AbSorber XM-ONE Transplantation Cross Match, ABX100-03 |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | AbSorber XM-ONE Transplantation Cross Match (ABX100-03), containing a certain lot of BD Vacutainer Cell Preparation Tubes (CPT) which has the potential for poor separation resulting in a reduced… |
| Initiation date | Jul 7, 2014 |
| Report date | Sep 17, 2014 |
| Termination date | Jan 20, 2015 |
| City | Stockholm |
| Country | Sweden |
| FEI number | 3002522915 |
At a glance
- 1–9 Products in this recall
- 1–9 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: