Class II — Potential Health Hazard

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

bioMerieux Kit Recalled by Biomerieux Inc Due to Mislabeling

Date: October 16, 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

bioMerieux Kit, Instrument & Update, B.40, 3D I ZIP-ML01, Industry instrument software update, English, Spanish, Italian, catalog number 413483 Software update for an instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin.

Quantity: 33 kits

Why Was This Recalled?

The product may mislabel patient information on culture specimen bottles due to a software miscommunication.

Where Was This Sold?

This product was distributed to 19 states: AZ, AR, CA, FL, KS, LA, MD, MN, MT, NV, NY, NC, OR, PA, RI, SC, TX, VA, WA

Affected (19 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