ClearanceBrief
Recall Z-0479-2010 ยท JIX Calibrator, Multi-Analyte Mixture

Cargille-Sacher Laboratories Inc.

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;

DateDec 1, 2009 (initiated Jul 7, 2006)
StatusTerminated
ReasonThe 10 ml size standard of Cargille modified Kingsbury Clark Albumin Standards of lot Jan-12-05 appear shrunken or liquefied.
Root causeStorage
ActionCargill sent recall letters mailed July 7, 2006 by first class mail.
Quantity5 kits
DistributionThe product was distributed to 5 customers in OH, Washington, DC, PA, WI, and VA.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.