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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 Device Recall Cargille Modified KingsburyClark Albumin Standards see related information
Date Initiated by Firm July 07, 2006
Date Posted December 01, 2009
Recall Status1 Terminated 3 on December 02, 2009
Recall Number Z-0479-2010
Recall Event ID 52121
Product Classification in vitro Diagnostic - 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 NJ 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		 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 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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