Abbott AxSYM Matrix Cells--Product List No: 8A73-02, sold in boxes of 100
This recall has been terminated (originally issued November 17, 2006).
- Recall Initiated
- September 8, 2006
- Posted
- November 17, 2006
- Terminated
- January 24, 2012
- Recall Number
- Z-0117-2007
- Quantity
- 2,355 boxes of 100
- Firm Location
- Barceloneta, PR
- Official Source
- View on FDA website ↗
Reason for Recall
Increase in complaints regarding controls out of range, calibration errors, and discrepant patient results with the AxSYM Troponin-I ADV assay.
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
Lot / Code Info
Lot # 37618Q100 Expiration Date 12/05/2006
Root Cause
Other
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