AxSYM Ultrasensitive hTSH II Master Calibrators Microparticle Enzyme Immunoassay that determines amount of human thyroid stimulating hormone in human serum and plasma.
- Recall Initiated
- March 6, 2008
- Posted
- July 24, 2008
- Terminated
- January 25, 2012
- Recall Number
- Z-1566-2008
- Quantity
- 882 total units
- Firm Location
- Barceloneta, PR
Reason for Recall
High Control value out of range after calibration. --AN INCREASED FREQUENCY OF HIGH CONTROL VALUES BEYOND THE UPPER LIMIT OF THE RANGE SPECIFIED BY THE PACKAGE INSERT.
Distribution
Worldwide Distribution --- USA including states of AZ, CA, CO, FL, GA, ID, IL, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NY, OH, OK, PA, RI, SC, SD, TN, TX, WA, WI, WV, and WY, and Puerto Rico, and countries of Canada, Mexico, Brazil, Chile, Germany, Japan, and Hong Kong.
Lot / Code Info
Lot 50082Q100 Exp Date 02/23/2008, Lot 52369Q100 Exp Date 04/20/2008, Lot # 53620Q100 Exp Date 06/26/2008 and Lot # 57518Q100 Exp Date 09/07/2008
Root Cause
Nonconforming Material/Component
Action Taken
The firm issued Product Recall letters dated February 22, 2008, requesting remaining units of the affected product be discontinue using and destroyed. A Customer Reply Immediate Action Required letter was enclosed to indicate acknowledging receipt of the product recall letter and to provide information on the number of kits destroyed before March 7, 2008 and faxed to 1-800-777-0051.