Reported Nov 28, 2012 · Terminated

bioMerieux BacT/ALERT Combo Module, catalog number, 200290, Clinical instrument The product is most commonly used to…

Biomerieux Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Biomerieux Inc · 595 Anglum Rd · Hazelwood, MO · 63042-2320

Is this the product you have?

  • bioMerieux BacT/ALERT Combo Module, catalog number, 200290, Clinical instrument The product 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.
Lot codes and dates
  • Identified by B.40 firmware
Amount recalled
375 modules

This recall covers 32 products

The agency filed one notice per product. You are reading one of them; the other 31 are below.

19 more are in the archive.

Where it was sold

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Oct 28, 2013 · Data as of Sep 19, 4:53 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.