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Class 3 Device Recall Cargille Modified KingsburyClark Albumin Standards |
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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
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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;
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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
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For Additional Information Contact |
William Sacher 973-239-6633
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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.
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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
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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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