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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 Device Recall BacT/ALERT SA Blood Culture Bottlesee related information
Date Initiated by FirmDecember 25, 2012
Date PostedJanuary 25, 2013
Recall Status1 Terminated 3 on June 03, 2014
Recall NumberZ-0738-2013
Recall Event ID 64054
510(K)NumberK020931 
Product Classification System, blood culturing - Product Code MDB
ProductBacT/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
FEI Number 3002769706
Recalling Firm/
Manufacturer		 bioMerieux, Inc.
100 Rodolphe St
Durham NC 27712-9402
For Additional Information ContactRyan 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		Nonconforming Material/Component
ActionbioMerieux 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 Commerce1690 cases
DistributionWorldwide 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 CycleTPLC Device Report
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.
510(K) Database510(K)s with Product Code = MDB
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