Z-0302-2013Class II

bioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML01, Clinical instrument software, English, Spanish...

Name: Z-0302-2013 bioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML01, Clinical instrument software, English, Spanish...
Creator: Biomerieux Inc
Published: 2012-10-16
License: https://open.fda.gov/license/

bioMerieux, Inc. / initiated 2012-10-16 / Terminated / root cause: software

FDA source

Biomerieux Inc began a recall of bioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML01, Clinical instrument software, English, Spanish, Italian, catalog number 411814 Software update for the... on 2012-10-16. FDA classified it as Class II and gives the reason as "The product may mislabel patient information on culture specimen bottles due to a software miscommunication". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0302-2013
Classification: Class II
Status: Terminated
Initiated: 2012-10-16
Posted: 2012-11-16
Terminated: 2013-10-28
Recalling firm: bioMerieux, Inc.
Product: bioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML01, Clinical instrument software, English, Spanish, Italian, catalog number 411814 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.
Product code: MDB System, Blood Culturing
Reason for recall: The product may mislabel patient information on culture specimen bottles due to a software miscommunication.
Root cause tag: software
FDA root cause: Software design
Action: BIOMERIEUX sent an Urgent Product Correction Notice to all affected customers starting on October 16, 2012, The letter identified the affected product, the problem, and the action to be taken by hte customer. The firm provided modified instructions for use to clarify how to properly load bottles and to provide appropriate cautions and warnings concerning bottle loading. Customers were instructed to ensure that the letter and guidance on how to properly scan and load bottles is distributed, and training is provided to all appropriate personnel within their organization. Check for lost bottles in their system; fill out and return the Acknowledgement Form in Attachment A by fax to confirm receipt of the notice. Customers were instructed to contact their local bioMerieux Customers Service Representative with any questions. For questions regarding this recall call 919-620-2682.
Quantity in commerce: 1336 kits
Distribution: 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.
Product codes and lots: Identified by B.40 firmware

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0302-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0299-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-28	2012-11-16
Z-0300-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-28	2012-11-16
Z-0301-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-28	2012-11-16
Z-0302-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-28	2012-11-16
Z-0303-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-28	2012-11-16
Z-0304-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-28	2012-11-16
Z-0305-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-28	2012-11-16
Z-0306-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-28	2012-11-16
Z-0307-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-28	2012-11-16
Z-0308-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-28	2012-11-16
Z-0309-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-28	2012-11-16
Z-0310-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-28	2012-11-16
Z-0311-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-28	2012-11-16
Z-0312-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-28	2012-11-16
Z-0313-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-28	2012-11-16
Z-0314-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-28	2012-11-16
Z-0315-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-28	2012-11-16
Z-0316-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-28	2012-11-16
Z-0317-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-28	2012-11-16
Z-0318-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-28	2012-11-16
Z-0319-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-28	2012-11-16
Z-0320-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-28	2012-11-16
Z-0321-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-28	2012-11-16
Z-0322-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-28	2012-11-16
Z-0323-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-28	2012-11-16
Z-0324-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-28	2012-11-16
Z-0325-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-28	2012-11-16
Z-0326-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-28	2012-11-16
Z-0327-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-28	2012-11-16
Z-0328-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-28	2012-11-16
Z-0329-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-28	2012-11-16

Product code MDB

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)