BacT/ALERT¿ FA recalled over mold contamination

Recall date

December 24, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

bioMerieux, Inc. recalls BacT/ALERT¿ FA, bioM¿rieux, Inc., Product Usage: BacT/ALERT¿ Culture Bottles are used with the BacT/ALERT¿ Microbial De…

Recall number

Z-0750-2016

FDA classification

Class II

Brand / firm

bioMerieux, Inc.

Sold / distributed

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, Serbi…

Why it was recalled

Bottles may have been exposed to non-normal shipping conditions which may lead to media degradation and impact growth performance.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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).