Abbott Diagnostic International, Ltd. Carr # 2 Km 58.0 Cruce Davila AxSYM Ultrasensitive hTSH II Master Calibrators Microparticle Enzyme Immunoassay that determines amount of human thyroid stimulating hormone in human serum and plasma. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
AxSYM Ultrasensitive hTSH II Master Calibrators Microparticle Enzyme Immunoassay that determines amount of human thyroid stimulating hormone in human serum and plasma.
Brand
Abbott Diagnostic International, Ltd. Carr # 2 Km 58.0 Cruce Davila
Lot Codes / Batch Numbers
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
Products Sold
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
Abbott Diagnostic International, Ltd. Carr # 2 Km 58.0 Cruce Davila is recalling AxSYM Ultrasensitive hTSH II Master Calibrators Microparticle Enzyme Immunoassay that determines am due to High Control value out of range after calibration. --AN INCREASED FREQUENCY OF HIGH CONTROL VALUES BEYOND THE UPPER LIMIT OF THE RANGE SPECIFIED BY T. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AZ, CA, CO, FL, GA, ID, IL, KS, KY, LA, MD, MA, MI, MN, MS, MO, MT, NE, NJ, NM, NY, NC, OH, OK, PA, RI, SC, SD, TN, TX, WA, WV, WI, WY, PR
Page updated: Jan 10, 2026