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U.S. Department of Health and Human Services

Class 2 Device Recall BacT/ALERT SA Blood Culture Bottle

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 Class 2 Recall
BacT/ALERT SA Blood Culture Bottle
see related information
Date Posted January 25, 2013
Recall Status1 Terminated on June 03, 2014
Recall Number Z-0738-2013
Recall Event ID 64054
Premarket Notification
510(K) Number
K020931 
Product Classification System, Blood Culturing - Product Code MDB
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, North Carolina 27712-9402
For Additional Information Contact Ryan LeMelle
919-620-2599
Manufacturer Reason
for Recall
BacT/ALERT SA Culture Bottle lot 1031866 may contain bottles with uncured sensors.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): 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

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = MDB and Original Applicant = BIOMERIEUX, INC.
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