bioMerieux, Inc.: Medical Device Recall in 2016 - (Recall #: Z-0750-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

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).

Product Classification:

Class II

Date Initiated: December 24, 2015

Date Posted: February 10, 2016

Recall Number: Z-0750-2016

Event ID: 73027

Reason for Recall:

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

Status: Terminated

Product Quantity: 2741 units in total

Code Information:

Reference number: 259791, Lot number: 1042923, Expiry: 25JAN2016 and Lot number 1042979, Expiry: 28JAN2016.

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.

Voluntary or Mandated:

Voluntary: Firm initiated