BacT/ALERT¿ FA, bioM¿rieux, Inc., Product Usage: BacT/ALERT¿ Culture Bottles are used with th...
FDA Recall #Z-0750-2016 — Class II — December 24, 2015
Product Description
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).
Reason for Recall
Bottles may have been exposed to non-normal shipping conditions which may lead to media degradation and impact growth performance.
Recalling Firm
bioMerieux, Inc. — Durham, NC
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
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.
Code Information
Reference number: 259791, Lot number: 1042923, Expiry: 25JAN2016 and Lot number 1042979, Expiry: 28JAN2016.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated