Drug recall
Skin Tissue, AlloDerm/Repliform Regenerative Tissue Matrix.
FDA recall event 34826 · Class II · LifeCell Corporation
Key facts
| Event ID | 34826 |
|---|---|
| Recall numbers | B-1197-6 |
| Recalling firm | LifeCell Corporation |
| Product type | Biologics |
| Products | Skin Tissue, AlloDerm/Repliform Regenerative Tissue Matrix. |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Skin Tissue, that was subsequently found to test repeatedly reactive for antibodies to Hepatitis B Core Total (igM/IgG) by a different facility, was distributed. |
| Initiation date | Jan 30, 2006 |
| City | Somerville |
| Country | United States |
| FEI number | 1000306051 |
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