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Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCAR Recall
Reference Number: mdprc 124 07 13 000
Date submitted: 7/18/2013
Manufacturer:bioMerieux Inc
Device Type:Analyzer, Microbiology, VITEK 2 systems
Description:Analyzer, Microbiology, Identification , Antibiotic susceptibility
Medical Device Identifier:V.6.01 software , Lot No : see attached file
Reason of Field Safety Corrective Action:During the update of software from version 5.xx to 6.01, the Bi-directional Computer Interface (BCI) antibiotic codes are not updated properly for Cefovecin (CFO), Prulifloxacin (PRU) and Ceftaroline (CTL). For the referenced antibiotics, the bioMérieux code in the reference table does not match the default host code in version 6.01 software.
Remedy Action:1 / Ensure this Urgent Product Correction Notice and the Instructions for modifying BCI Translation Codes (Attachment) are distributed to all appropriate personnel in your organization 2 / 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 3 / bioMérieux will incorporate a software solution to prevent this issue from occurring, in the next software update, version 7.01 targeted for launch at the end of 2013
Athorized Representative/Importer/Distributor:Al-Jeel Medical & Trading Co. LTD , Riyadh (011) 4041717
Report Source:NCAR
Source Ref. Number:FR-2013-07-10-040
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: BioMerieux.pdf