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U.S. Department of Health and Human Services

Class 3 Device Recall Cargille Modified KingsburyClark Albumin Standards

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 Class 3 Recall
Cargille Modified KingsburyClark Albumin Standards
see related information
Date Posted December 01, 2009
Recall Status1 Terminated on December 02, 2009
Recall Number Z-0479-2010
Recall Event ID 52121
Product Classification Calibrator, Multi-Analyte Mixture - Product Code JIX
Product Cargille Modified Kingsbury-Clark Albumin Standards For in vitro Diagnostics (Set of 8 Standards: 5, 10, 20, 30, 40, 50, 75, 100 mg/ml); Catalog number: 52064;
Code Information Catalog number: 52064; Lot number: Jan-12-05
Recalling Firm/
Manufacturer
Cargille-Sacher Laboratories Inc.
55 Commerce Rd
Cedar Grove, New Jersey 07009-1205
For Additional Information Contact William Sacher
973-239-6633
Manufacturer Reason
for Recall
The 10 ml size standard of Cargille modified Kingsbury Clark Albumin Standards of lot Jan-12-05 appear shrunken or liquefied.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Storage
Action Cargill sent recall letters mailed July 7, 2006 by first class mail.
Quantity in Commerce 5 kits
Distribution The product was distributed to 5 customers in OH, Washington, DC, PA, WI, and VA.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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