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U.S. Department of Health and Human Services

Class 2 Device Recall bioMerieux Vitek 2 Systems Software version 6.01 software

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  Class 2 Device Recall bioMerieux Vitek 2 Systems Software version 6.01 software see related information
Date Initiated by Firm June 14, 2013
Date Posted August 06, 2013
Recall Status1 Terminated 3 on June 01, 2015
Recall Number Z-1912-2013
Recall Event ID 65470
Product Classification Susceptibility test cards, antimicrobial - Product Code LTW
Product bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 ES. Part number: 414561.

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.
Code Information version 6.01
Recalling Firm/
Biomerieux Inc
595 Anglum Rd
Hazelwood MO 63042-2320
For Additional Information Contact Ryan LeMelle
Manufacturer 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
FDA Determined
Cause 2
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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.