Class 2 Device Recall BacT/ALERT SN

• Date Initiated by Firm: December 24, 2015
• Create Date: February 04, 2016
• Recall Status: Terminated on December 04, 2017
• Recall Number: Z-0749-2016
• Recall Event ID: 73027
• 510(K)Number: K993421
• Product Classification: System, blood culturing - Product Code MDB
• Product: BacT/ALERT SN, bioMrieux, 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: 259790, Lot number: 1042739, Expiry: 09JAN2016.
• 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: 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 bioMrieux 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