Z-1911-2013Class II

bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT...

Name: Z-1911-2013 bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT...
Creator: Biomerieux Inc
Published: 2013-06-14
License: https://open.fda.gov/license/

bioMerieux, Inc. / initiated 2013-06-14 / Terminated / root cause: software

FDA source

Biomerieux Inc began a recall of bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 EN. Part number: 414560. The product is... on 2013-06-14. FDA classified it as Class II and gives the reason as "A product issue has been identified for customers using software version 6.01 and are interfaced with a Laboratory Information System (LIS). During the update of software from version 5.xx to 6.01, the Bid-directional...". 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-1911-2013
Classification: Class II
Status: Terminated
Initiated: 2013-06-14
Posted: 2013-08-06
Terminated: 2015-06-01
Recalling firm: bioMerieux, Inc.
Product: bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 EN. Part number: 414560. The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast.
Product code: LTW Susceptibility Test Cards, Antimicrobial
Reason for recall: A product issue has been identified for customers using software version 6.01 and are interfaced with a Laboratory Information System (LIS). During the update of software from version 5.xx to 6.01, the Bid-directional Computer interface (BCI) antibiotic codes are not updated properly for Cefovecin, Prulifloxacin and Ceftaroline. For the referenced antibiotics, the firm code in the reference table
Root cause tag: software
FDA root cause: Software change control
Action: The firm, bioMerieux, sent an "Urgent Product Correction Notice" letter dated June 14, 2013 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to ensure the Urgent Product Correction Notice and the Instructions for modifying BCI Translation Codes are distributed to all appropriate personnel in your organization; follow the instructions in the attached file (Instructions for modifying BCI Translation Codes) to resolve the discrepancy associated with Cefovecin, Prulifloxacin and Ceftaroline in the translation table and complete and return the Attachment A: Acknowledgement Form via Fax to: Attn: RA North American ComOps at (919)287-2542. If you require additional assistance or have any questions, please contact your local bioMerieux Clinical Customer Service organization at (800) 682-2666 or Industrial Customer Service organization at (800) 634-7656.
Quantity in commerce: 12,384 total kits
Distribution: Worldwide distribution: US (nationwide) and countries of: Argentina, Australia, Austria, Bahrain, Belarus, Benelux, Brazil, Bulgaria, Canada, Chile China, Costa Rica, Croatia, Czech Republic, Dominican Republic, Dutch Antilles, Ecuador, Egypt, France, Germany, Hong Kong, Hungary, India, Indonesia, Israel, Italy, Japan, Kazakhstan, Korea, Kuwait, Libya, Lithuania, Macedonia, Malaysia, Malta, Mexico, Morocco, Myanmar, Netherlands, Nicaragua, Nigeria, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Romania, Russia, Serbia, Singapore, Slovenia, Spain, Sweden, Switzerland, South Africa, Thailand, Tunisia, United Arab Emirates, United Kingdom, Uruguay, and Vietnam.
Product codes and lots: version 6.01

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1911-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1907-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-14	2013-08-06
Z-1908-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-14	2013-08-06
Z-1909-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-14	2013-08-06
Z-1910-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-14	2013-08-06
Z-1911-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-14	2013-08-06
Z-1912-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-14	2013-08-06
Z-1913-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-14	2013-08-06
Z-1914-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-14	2013-08-06
Z-1915-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-14	2013-08-06
Z-1916-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-14	2013-08-06
Z-1917-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-14	2013-08-06
Z-1918-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-14	2013-08-06
Z-1919-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-14	2013-08-06
Z-1920-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-14	2013-08-06
Z-1921-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-14	2013-08-06

Product code LTW

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)