Abbott AxSYM Matrix Cells--Product List No: 8A73-02, sold in boxes of 100
FDA device recall Z-0117-2007 · posted 2006-11-17 · Terminated
Recall details
- Recalling firm
- Abbott Diagnostic International, Ltd.
- Reason for recall
- Increase in complaints regarding controls out of range, calibration errors, and discrepant patient results with the AxSYM Troponin-I ADV assay.
- Root cause
- Other
- Status
- Terminated
- Product code
- JJE
- Quantity affected
- 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 Pu
- Date initiated
- 2006-09-08
- Date posted
- 2006-11-17
- Date terminated
- 2012-01-24
- Location
- Barceloneta, PR
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ABBOTT AXSYM TROPONIN-I ADV (K041811) | Abbott Laboratories | 2004-09-10 |
| ABBOTT AXSYM SYSTEM (K974651) | Abbott Laboratories | 1998-02-12 |