Biomerieux Inc: Medical Device Recall in 2012 - (Recall #: Z-0430-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

0.9% Sodium Chloride Injections, USP, 1000ml, VWR/Baxter Product Usage: The concentrated sodium chloride is used to prepare inoculum that is analyzed by the VITEK 2 instrument. The VITEK 2 user manual instructs all users to prepare inoculum with 0.45%-0.50% sodium chloride injections, and the system is designed to use 0.45%-0.50% sodium chloride concentration only.

Product Classification:

Class II

Date Initiated: October 17, 2012

Date Posted: November 28, 2012

Recall Number: Z-0430-2013

Event ID: 63479

Reason for Recall:

The firm inventoried and distributed 0.9% Sodium Chloride Saline bags as 0.45% Sodium Chloride Saline bags for use with the VITEK 2 system.

Status: Terminated

Product Quantity: 199 cases/14-1000mL bags

Code Information:

Lot number C866715, EXP OCT 13

Distribution Pattern:

Worldwide Distribution - USA (nationwide) including the states of: AL, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OK, PA, RI, TN, TX, VA and WI. Distribution was also made to Canada, military facilities and other foriegn countries.

Voluntary or Mandated:

Voluntary: Firm initiated