Recall Z-1566-2008 ยท JIS Calibrator, Primary
Abbott Diagnostic International, Ltd.
AxSYM Ultrasensitive hTSH II Master Calibrators Microparticle Enzyme Immunoassay that determines amount of human thyroid stimulating hormone in human serum and plasma.
| Date | Jul 24, 2008 (initiated Mar 6, 2008) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Nonconforming Material/Component |
| Action | 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. |
| Quantity | 882 total units |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K952148 | AXSYM ULTRASENSITIVE HTSH II Abbott Laboratories, Jun 29, 1995 |