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Class 2 Device Recall BacT/ALERT SA Blood Culture Bottle |
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Date Initiated by Firm |
December 25, 2012 |
Date Posted |
January 25, 2013 |
Recall Status1 |
Terminated 3 on June 03, 2014 |
Recall Number |
Z-0738-2013 |
Recall Event ID |
64054 |
510(K)Number |
K020931
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Product Classification |
System, blood culturing - Product Code MDB
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Product |
BacT/ALERT SA Blood Culture Bottle.
The BacT/ALERT SA reagent bottle is intended to be recover and detect aerobic microorganisms (bacteria and fungi) from blood and other normally sterile body fluids. |
Code Information |
Catalog Number: 259789, Lots/Batch: 1031866 |
Recalling Firm/ Manufacturer |
bioMerieux, Inc. 100 Rodolphe St Durham NC 27712-9402
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For Additional Information Contact |
Ryan LeMelle 919-620-2599
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Manufacturer Reason for Recall |
BacT/ALERT SA Culture Bottle lot 1031866 may contain bottles with uncured sensors.
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FDA Determined Cause 2 |
Nonconforming Material/Component |
Action |
bioMerieux sent an "URGENT PRODUCT REMOVAL NOTICE" and Acknowledgement Form on January 4, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers.
Contact your local bioMerieux Customer Service Representative for additional assistance. |
Quantity in Commerce |
1690 cases |
Distribution |
Worldwide Distribution.USA including the states of AR, AZ, CA, CO, DE, FL, GA, IL, IN, KY, LA, MD, MI, MN, MO, NC, NJ, NY, OH, OR, PA, RI, SC, SD, TN, TX, VA, WI, and WV, and the countries of China, Curacao and Japan. |
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 = MDB and Original Applicant = BIOMERIEUX, INC.
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