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Class 2 Device Recall Abbott AxSYM Matrix Cells |
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| Date Initiated by Firm |
September 08, 2006 |
| Date Posted |
November 17, 2006 |
| Recall Status1 |
Terminated 3 on January 24, 2012 |
| Recall Number |
Z-0117-2007 |
| Recall Event ID |
36417 |
| 510(K)Number |
K974651 K041811
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| Product Classification |
Matrix Cells - Product Code JJE
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| Product |
Abbott AxSYM Matrix Cells--Product List No: 8A73-02, sold in boxes of 100 |
| Code Information |
Lot # 37618Q100 Expiration Date 12/05/2006 |
Recalling Firm/
Manufacturer |
Abbott Diagnostic International, Ltd.
Carr 2 Km 58.0
Cruce Davila
Barceloneta PR 00617-3009
|
Manufacturer Reason
for Recall |
Increase in complaints regarding controls out of range, calibration errors, and discrepant patient results with the AxSYM Troponin-I ADV assay.
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FDA Determined
Cause 2 |
Other |
| Quantity in Commerce |
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 |
| Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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| 510(K) Database |
510(K)s with Product Code = JJE and Original Applicant = ABBOTT LABORATORIES
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