PlainRecalls
FDA Devices Moderate Class II Terminated

BacT/ALERT¿ SN, 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).

Reported: February 10, 2016 Initiated: December 24, 2015 #Z-0749-2016

Product Description

BacT/ALERT¿ SN, 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.

Details

Recalling Firm
bioMerieux, Inc.
Units Affected
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.
Location
Durham, NC

Frequently Asked Questions

What product was recalled?
BacT/ALERT¿ SN, 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).. Recalled by bioMerieux, Inc.. Units affected: 2741 units in total.
Why was this product recalled?
Bottles may have been exposed to non-normal shipping conditions which may lead to media degradation and impact growth performance.
Which agency issued this recall?
This recall was issued by the FDA Devices on February 10, 2016. Severity: Moderate. Recall number: Z-0749-2016.