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Medical Devices Sector
قطاع الأجهزة الطبية
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NCMDR Recall
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Reference Number:
mdprc 092 07 18 000
Date submitted:
7/18/2018
Manufacturer:
bioMerieux Inc
Device Type:
VIDAS CA 15-3
Description:
IVDs
Medical Device Identifier:
VIDAS CA 15-3 (Ref. 30429) lots 1006022590 and 1006251930
Reason of Field Safety Corrective Action:
Following customers’ complaints for calibrations out of range (Standard S1 out of range low and/or Control C1 out of range high) when using VIDAS CA 15-3 lots 1006022590 and 1006251930, investigators confirmed a defect on the identified products and reproduced the issue reported by the customers.
Remedy Action:
• Destroy the impacted lots: VIDAS CA 15-3 (Ref. 30429) lots 1006022590 and 1006251930.
• If you wish to be supplied with a replacement VIDAS CA15-3 kit, please call your bioMérieux local representative that will give your laboratory the appropriate support.
Athorized Representative/Importer/Distributor:
Al-Jeel Medical & Trading Co. LTD
Report Source:
NCMDR
Source Ref. Number:
947F55F7F9358
SFDA Comments:
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:
BioMerioux.pdf
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