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قطاع الأجهزة الطبية
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NCMDR Recall
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Reference Number:
mdprc 006 06 13 000
Date submitted:
6/2/2013
Manufacturer:
MAST International Ltd
Device Type:
IVD,CIPROFLOXACIN 1ug CARTRIDGE DISCS
Description:
Antibiotic Susceptibility
Medical Device Identifier:
Cat:CIP1C / Lot No:316356
Reason of Field Safety Corrective Action:
The investigation revealed that discs may be producing zones of inhibition that exceed the expected quality control
Remedy Action:
It is recommended that use of this batch of discs within your laboratory is discontinued immediately whether or not any unexpected results have been noted
Athorized Representative/Importer/Distributor:
Al Nahir Trading Co , Riyadh , (011) 4770444
Report Source:
NCMDR
Source Ref. Number:
4BBCA22C221F7
SFDA Comments:
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:
Mast Group.pdf
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