Medical Device
Manufacturing
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Z-0479-2010

Cargille Modified Kingsbury-Clark Albumin Standards For in vitro Diagnostics (Set of 8 Standards: 5, 10, 20...

Cargille-Sacher Laboratories Inc. / initiated 2006-07-07 / Terminated

Cargille-Sacher Laboratories Inc. began a recall of 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 on . The reason FDA records is "The 10 ml size standard of Cargille modified Kingsbury Clark Albumin Standards of lot Jan-12-05 appear shrunken or liquefied". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0479-2010
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Cargille-Sacher Laboratories Inc.
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;
Product code
JIX Calibrator, Multi-Analyte Mixture
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 root cause
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.
Product codes and lots
Catalog number: 52064; Lot number: Jan-12-05