Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

0.9% Sodium Chloride Injections Recalled by Biomerieux Inc Due to The firm inventoried and distributed 0.9% Sodium Chloride...

Date: October 17, 2012
Company: Biomerieux Inc
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Biomerieux Inc directly.

Affected Products

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.

Quantity: 199 cases/14-1000mL bags

Why Was This Recalled?

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.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Biomerieux Inc

Biomerieux Inc has 368 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report