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

Kit, Instrument & Update, 3D B.40 USB-ML06, Clinical instrument recalled

Biomerieux is recalling Kit, Instrument & Update, 3D B.40 USB-ML06, Clinical instrument, distributed in 19 states. 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 recalled69 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-0317-2013
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, Instrument & Update, 3D B.40 USB-ML06, Clinical instrument software, Japanese, Korean, Norwegian, Brazilian, Portuguese, Turkish, catalog number 412622 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.

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

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

Other products in this recall event

30 other products · FDA event 63467

This product is part of a recall event; the main page for the event is Kit, Instrument & Update, B.40 Dualt-ML, Industry instrument recalled.

Reported	Class	Recall	Company	Reason	Where
28 Nov 2012	CLASS II	Kit, Instrument & Update, B.40 Dualt-ML, Industry instrument recalled	Biomerieux	Labeling Errors	19 states
28 Nov 2012	CLASS II	Kit, Instrument & Update, 3D IND Usb-ml 02, Industry instrument recalled	Biomerieux	Labeling Errors	19 states
28 Nov 2012	CLASS II	Kit, Instrument & Update, 3D B.40 USB-ML05, Clinical instrument recalled	Biomerieux	Labeling Errors	19 states
28 Nov 2012	CLASS II	Kit, Instrument & Update, 3D B.40 ZIP-ML04, Clinical instrument recalled	Biomerieux	Labeling Errors	19 states
28 Nov 2012	CLASS II	Kit, Instrument & Update, B.40, 3D I USB-ML01, Industry instrument recalled	Biomerieux	Labeling Errors	19 states
28 Nov 2012	CLASS II	Kit, Instrument & Update, B.40, 3D I ZIP-ML02, Industry instrument recalled	Biomerieux	Labeling Errors	19 states
28 Nov 2012	CLASS II	Kit, Instrument & Update, 3D B.40 ZIP-ML05, Clinical instrument recalled	Biomerieux	Labeling Errors	19 states
28 Nov 2012	CLASS II	Kit, Instrument & Update, 3D B.40 Zip-ml 02, Clinical instrument recalled	Biomerieux	Labeling Errors	19 states
28 Nov 2012	CLASS II	Kit, Instrument & Update, 3D B.40 ZIP-ML01, Clinical instrument recalled	Biomerieux	Labeling Errors	19 states
28 Nov 2012	CLASS II	Kit, Instrument & Update, 3D B.40 USB-ML01, Clinical instrument recalled	Biomerieux	Labeling Errors	19 states
28 Nov 2012	CLASS II	Kit, USB HDW, BTA3D Combo-b-b.40, Clinical instrument recalled	Biomerieux	Labeling Errors	19 states
28 Nov 2012	CLASS II	Kit, USB HDW, BTA3D60-B-B.40, Clinical instrument recalled by Biomerieux	Biomerieux	Labeling Errors	19 states
28 Nov 2012	CLASS II	BacT/Alert Combo Module recalled by Biomerieux	Biomerieux	Labeling Errors	19 states
28 Nov 2012	CLASS II	BacT/Alert Control Module recalled by Biomerieux	Biomerieux	Labeling Errors	19 states
28 Nov 2012	CLASS II	BacT/Alert Combo Module recalled by Biomerieux	Biomerieux	Labeling Errors	19 states
28 Nov 2012	CLASS II	Kit, Instrument & Update, B.40, 3D IND USB-ML01, Industry instrument recalled	Biomerieux	Labeling Errors	19 states
28 Nov 2012	CLASS II	Kit, USB Instrument & Update, 3D B.40 USB-ML03, Clinical instrument recalled	Biomerieux	Labeling Errors	19 states
28 Nov 2012	CLASS II	Kit, Instrument & Update, B.40, 3D IND USB-ML02, Industry instrument recalled	Biomerieux	Labeling Errors	19 states
28 Nov 2012	CLASS II	Kit, Instrument & Update, 3D B.40 ZIP-ML03, Clinical instrument recalled	Biomerieux	Labeling Errors	19 states
28 Nov 2012	CLASS II	Kit, Instrument & Update, B.40, 3D I ZIP-ML01, Industry instrument recalled	Biomerieux	Labeling Errors	19 states
28 Nov 2012	CLASS II	Kit, USB HDW, BTA3D Control-b-b.40, Clinical instrument recalled	Biomerieux	Labeling Errors	19 states
28 Nov 2012	CLASS II	BacT/Alert Control Module recalled by Biomerieux	Biomerieux	Labeling Errors	19 states
28 Nov 2012	CLASS II	Kit, Instrument & Update, 3D B.40 ZIP-ML06, Clinical instrument recalled	Biomerieux	Labeling Errors	19 states
28 Nov 2012	CLASS II	Kit, Instrument & Update, 3D B.40 BTA3D-ZH01, Clinical instrument recalled	Biomerieux	Labeling Errors	19 states
28 Nov 2012	CLASS II	Kit, Instrument & Update, B.40, 3D I USB-ML02, Industry instrument recalled	Biomerieux	Labeling Errors	19 states
28 Nov 2012	CLASS II	Kit, Instrument & Update, 3D B.40 USB-ML04, Clinical instrument recalled	Biomerieux	Labeling Errors	19 states
28 Nov 2012	CLASS II	BacT/Alert 3D recalled by Biomerieux	Biomerieux	Labeling Errors	19 states
28 Nov 2012	CLASS II	BacT/Alert Combo Module recalled by Biomerieux	Biomerieux	Labeling Errors	19 states
28 Nov 2012	CLASS II	Kit, Instrument & Update, 3D B.40 USB-ML02, Clinical instrument recalled	Biomerieux	Labeling Errors	19 states
28 Nov 2012	CLASS II	Kit, Instrument & Update, 3D IND Zip-ml 01, Industry instrument recalled	Biomerieux	Labeling Errors	19 states

More recalls from Biomerieux

All 476

Reported	Class	Recall	Company	Reason	Where
15 Jul 2026Device	CLASS II	Vitek 2 Ast-N447 Test Kit Product reference recalled by Biomerieux	Biomerieux	Other	MO
11 Feb 2026Device	CLASS II	Vitek-negative Susceptibility Cards Containing o Polymyxin recalled	Biomerieux	Sterility	Nationwide
8 Oct 2025Device	CLASS II	Vitek¿-negative AST Test Kits (Cards) recalled by bioMerieux	bioMerieux	Sterility	NC
1 May 2024Device	CLASS I	Vitek 2 - AST Test kits (in vitro diagnostic test cards recalled	Biomerieux	Other	MO
8 Mar 2023Device	CLASS II	Myla comprises Ast Filters in conjunction with Vitek MS recalled	Biomerieux	Other	Nationwide

Other Heart & Vascular Devices recalls

All 6,199

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS II	Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled	Atrium Medical	Potency & Assay	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes: *Bardex¿ I.C recalled	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes recalled by C.R. Bard	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes recalled by C.R. Bard	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Getinge PVC Thoracic Catheter, Firm PVC Straight recalled	Atrium Medical	Potency & Assay	Nationwide