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U.S. Department of Health and Human Services

Class 2 Device Recall BacT/ALERT FA

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  Class 2 Device Recall BacT/ALERT FA see related information
Date Initiated by Firm December 24, 2015
Create Date February 04, 2016
Recall Status1 Terminated 3 on December 04, 2017
Recall Number Z-0750-2016
Recall Event ID 73027
510(K)Number K020813  
Product Classification System, blood culturing - Product Code MDB
Product BacT/ALERT¿ FA, bioM¿rieux, Inc.,

Product Usage:
BacT/ALERT¿ 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 (bacteria and yeast).
Code Information Reference number: 259791, Lot number: 1042923, Expiry: 25JAN2016 and Lot number 1042979, Expiry: 28JAN2016.
Recalling Firm/
Manufacturer		 bioMerieux, Inc.
100 Rodolphe St
Durham NC 27712-9402
For Additional Information Contact Jonathan Nonnemacher
919-620-3396
Manufacturer Reason
for Recall		 Bottles may have been exposed to non-normal shipping conditions which may lead to media degradation and impact growth performance.
FDA Determined
Cause 2		 Packaging process control
Action Biomerieux sent a Product Recall Notice letter to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to discontinue use of the referenced part and lot number and discard remaining inventory according to their facility's procedure for culture media. Customers were also instructed to contact their local bioM¿rieux representative for product replacement.
Quantity in Commerce 2741 units in total
Distribution Distributed in the countries of Angola, Austria, Bosnia, Bulgaria, Cameroon, Czech Republic, Democratic Republic of Congo, France, Germany, Greece, Hungary, Italy, Kazakhstan, Kingdom of Saudi Arabia, Kosovo, Lebanon, Netherlands, Niger, Pakistan, Poland, Republic of Belarus, Romania, Russia, Serbia, Sri Lanka, Spain, Sweden, Switzerland, United Arab Emirates, Turkey and Zimbabwe.
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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