Recall Z-0117-2007 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Abbott Diagnostic International, Ltd.
Abbott AxSYM Matrix Cells--Product List No: 8A73-02, sold in boxes of 100
| Date | Nov 17, 2006 (initiated Sep 8, 2006) |
| Status | Terminated |
| Reason | Increase in complaints regarding controls out of range, calibration errors, and discrepant patient results with the AxSYM Troponin-I ADV assay. |
| Root cause | Other |
| Quantity | 2,355 boxes of 100 |
| Distribution | Nationwide including the states of AL, AK, AZ, CA, CT, CO, DE, FL, GA, ID, IL, IA, IN, KS, KY, LA, MA, ME, MI, MS, MN, MT, MO, NM, NJ, NY, NV, OH, OK, PA, RI, SC, TN, TX, UT, VA, WA, WI, Hawaii and Puerto Rico |
| FDA record | Open on fda.gov |