SFDA National Center for Medical Devices Reporting

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Medical Devices Sector قطاع الأجهزة الطبية	NCMDR National Center for Medical Devices Reporting المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
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NCMDR Recall

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Reference Number:	mdprc 126 07 18 000
Date submitted:	7/24/2018

Manufacturer:	Mast Group Ltd.
Device Type:	Ciprofloxacin 0.5mg/L Plate
Description:	IVD, This product is used for determining susceptibility of urinary tract infections (UTI) caused by Enterobacterales only
Medical Device Identifier:	MPM-CIP0.5, lot: 408525, expiry 05/08/2018
Reason of Field Safety Corrective Action:	Mast has identified a potential problem with the above batch of Ciprofloxacin 0.5μg 96-well plates which relates to a small number of Mast Uri Plates MPM-CIP0.5 lot 408525, that appear to be exhibiting reduced Ciprofloxacin activity.
Remedy Action:	We request that you complete the acknowledgement in Attachment A. Please identify on the form numbers of all used plates from this batch and any unused plates still in your possession. Please discard any plates of this batch left in your stock and confirm the action you have taken on the reconciliation table in Attachment A.
Athorized Representative/Importer/Distributor:	Al Nahir Trading Co
Report Source:	NCMDR
Source Ref. Number:	14594A3170158
SFDA Comments:	SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:	Mast Group.pdf

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