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).
FDA Recall Z-0749-2016 · Posted None
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Recalling FirmbioMerieux, Inc.
Recall StatusTerminated
Product CodeMDB
Date Initiated2015-12-24
Date Terminated2017-12-04
Product Quantity2741 units in total
Reason for Recall
Bottles may have been exposed to non-normal shipping conditions which may lead to media degradation and impact growth performance.
Firm 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.
Root Cause
Packaging process control
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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