AlloCraft DBM with Syringe Assembly, 10 CC, LifeCell Corporation, Branchburg, NJ 08876 , Distributed by Stryker Spine
FDA device recall Z-1299-2008 · posted 2008-03-26 · Terminated
Recall details
- Recalling firm
- LifeCell Corporation
- Reason for recall
- Improper donor screening test; diagnostic test kits were used in lieu of a donor screening test kits for HBsAG and HBcAB (later re-testing with FDA-approved donor screening test found samples non-reactive for both Hepatitis B Surface Antigen and Hepatitis B Core IgM/IgG Antibody)
- Action taken
- Consignee was notified by telephone, followed by a Recall letter sent by FAX on October 17, 2007 requesting return of any unused product.
- Root cause
- Release of Material/Component prior to receiving test results
- Status
- Terminated
- Product code
- MQV
- Quantity affected
- 110 kits
- Distribution
- All syringe assemblies were distributed to Stryker Orthopaedics, Mahwah, NJ.
- Date initiated
- 2007-10-17
- Date posted
- 2008-03-26
- Date terminated
- 2008-05-14
- Location
- Somerville, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ALLOCRAFT DBM (K052735) | Lifecell Corp. | 2005-12-28 |