Drug recall
Micro SSPTM Allele Specific HLA Class I DNA Typing Tray - B*35 510(K) Number 8K 960062 Product number SSPR1-35…
FDA recall event 52053 · Class II · One Lambda Inc
Key facts
| Event ID | 52053 |
|---|---|
| Recall numbers | B-2457-12 |
| Recalling firm | One Lambda Inc |
| Product type | Biologics |
| Products | Micro SSPTM Allele Specific HLA Class I DNA Typing Tray - B*35 510(K) Number 8K 960062 Product number SSPR1-35 Product Insert Number SSP_DNAT_PIEN Rev 16 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | HLA typing assay, associated with false negative results, was distributed. |
| Initiation date | Mar 6, 2012 |
| Report date | Sep 5, 2012 |
| Termination date | Aug 28, 2012 |
| City | Canoga Park |
| State | CA |
| Country | United States |
| FEI number | 2024375 |
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: