CLASS II Device recall · Reported 28 Nov 2012 · FDA Enforcement Report

Kit, USB HDW, BTA3D Combo-b-b.40, Clinical instrument recalled

Biomerieux is recalling bioMerieux Kit, USB HDW, BTA3D Combo-b-b.40, Clinical instrument, distributed nationwide in the US. The recall was initiated on 16 Oct 2012 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesIdentified by B.40 firmware

Quantity recalled205 kits

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0312-2013
FDA event ID: 63467
Recalling firm: Biomerieux, Hazelwood, MO
Classification: Class II
Status: Terminated
Recall initiated: 16 Oct 2012
FDA classified: 16 Nov 2012
Reported: 28 Nov 2012
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Labeling Errors
Device type: Heart & Vascular Devices

Timeline

16 Oct 2012	Recall initiated by company
16 Nov 2012	Classified by FDA	+31 days
28 Nov 2012	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

bioMerieux Kit, USB HDW, BTA3D COMBO-B-B.40, Clinical instrument software, USB update and mounting hardware-English, catalog number 411957 Software update for the clinical 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.

Where it was distributed

Worldwide Distribution - USA including AR, AZ, CA, FL, KS, LA, MD, MN, MT, NC, NV, NY, OR, PA, RI, SC, TX, VA and WA. Internationally to Argentina, Armenia, Austria, Bangladesh, Bosnia and Herzegowina, Brazil, Bulgaria, Burkina FASO, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, COTE DIVOIRE, CROATIA, CZECH REPUBLIC, DOMINICAN REPUBLIC, ECUADOR, EGYPT, EL SALVADOR, FRANCE, FRENCH POLYNESIA, GERMANY, GREECE, GUATEMALA, HONDURAS, HONG KONG, INDIA, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KENYA, REPUBLIC OF KOREA, KUWAIT, LATVIA, LITHUANIA, MALTA, MEXICO, NETHERLANDS, NEW CALEDONIA, NEW ZEALAND, PANAMA, PERU, POLAND, PORTUGAL, ROMANIA, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TUNISIA, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, UNITED STATES, URUGUAY, VENEZUELA, VIETNAM, PALESTINE, AND SERBIA.

Nationwide Arkansas Arizona California Florida Kansas Louisiana Maryland Minnesota Montana North Carolina Nevada New York Oregon Pennsylvania Rhode Island South Carolina Texas Virginia Washington

Questions about this recall

Is Kit, USB HDW, BTA3D Combo-b-b.40, Clinical instrument recalled?

Yes. Biomerieux recalled Kit, USB HDW, BTA3D Combo-b-b.40, Clinical instrument on 16 Oct 2012. The recall is Class II and its status is Terminated. Recall number Z-0312-2013.

Why was it recalled?

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

Which lots are affected?

Identified by B.40 firmware

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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