bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, V2S 6.01 RP5800-

FDA device recall Z-1907-2013 · posted 2013-08-06 · Terminated

Recall details

Recalling firm

Biomerieux Inc

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

Action taken

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.

Root cause

Software change control

Status

Terminated

Product code

LTW

Quantity affected

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, Dominica

Date initiated

2013-06-14

Date posted

2013-08-06

Date terminated

2015-06-01

Location

Hazelwood, MO