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Terminated

AlloCraft DBM with Syringe Assembly, 10 CC, LifeCell Corporation, Branchburg, NJ 08876 , Distributed by Stryker Spine

FDA Recall Z-1299-2008 · Posted 2008-03-26

Recalling FirmLifeCell Corporation
Recall StatusTerminated
Product CodeMQV
Date Initiated2007-10-17
Date Terminated2008-05-14
Product Quantity110 kits

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)

Firm Action

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

Distribution Pattern

All syringe assemblies were distributed to Stryker Orthopaedics, Mahwah, NJ.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K052735ALLOCRAFT DBMLifecell Corp. · 2005-12-28

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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