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U.S. Department of Health and Human Services

Class 2 Device Recall BacT/ALERT FA Reagent Bottle

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  Class 2 Device Recall BacT/ALERT FA Reagent Bottle see related information
Date Initiated by Firm April 13, 2011
Date Posted May 24, 2011
Recall Status1 Terminated 3 on April 03, 2012
Recall Number Z-2244-2011
Recall Event ID 58550
510(K)Number K020813  
Product Classification System, blood culturing - Product Code MDB
Product BacT/ALERT - FA Reagent Bottle
The BacT/ALERT Microbial Detection System is used to determine if microorganisms are present in blood or other normally sterile body fluid samples taken from a patient suspected of having bacteremial/fungemia. The BacT/ALERT System and culture bottles provide both a microbial detection system and a culture media with suitable nutritional and environmental conditions for organisms commonly encountered in blood infections and other normally sterile body fluid infections. An inoculated bottle is placed into the instrument where it is incubated and continuously monitored for the presence of microorganisms that will grow in the BacT/ALERT FA bottle. BacT/ALERT FA Culture Bottles are used with the BacT/ALERT Microbial Detection System in qualitative procedures for enhanced recovery and detection of aerobic and facultative anaerobic microorganisms (bacterial and fungi) from blood and other normally sterile body fluids.
Code Information Catalog number: 259791, Lot umber 1027481, Expiry: December 8, 2011
Recalling Firm/
Manufacturer		 bioMerieux, Inc.
100 Rodolphe St
Durham NC 27712-9402
For Additional Information Contact Benjamin Smith
314-731-8537
Manufacturer Reason
for Recall		 The charcoal suspension in a portion of the lot does not meet the intended density.
FDA Determined
Cause 2		 Other
Action BioMerieux sent an Urgent Product Removal Notice dated April 13, 2011, to all affected customers. The notice identified the product, the problem, and the action to be taken by the customer. Customers were instructed to: Evaluate positive results adhering to their institution's protocols for determining false versus true positives. Negative bottles should be checked by smear and/or subculture at some point prior to discarding as negative. Any remaining inventory of BacT/ALERT FA culture bottle lot 1027481 should be destroyed in accordance with their facility's policies and procedures. An Acknowledgement and Product Replacement Form was included to be completed and returned to bioMerieux or credit or replacement of unused bottles.
Quantity in Commerce 327,700 bottles
Distribution Worldwide Distribution - USA (nationwide) and the countries of China, Tokyo, South Korea, Canada, Sweden, Austria, Poland, and Belgium
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = MDB and Original Applicant = BIOMERIEUX, INC.
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