SFDA National Center for Medical Devices Reporting

X

Your changes have been successfully saved

Medical Devices Sector قطاع الأجهزة الطبية	NCMDR National Center for Medical Devices Reporting المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
Home Published FSNs/Recalls About NCMDR Contact Us FAQ Login

NCMDR Recall

Back

Reference Number:	mdprc 094 06 12 000
Date submitted:	6/18/2012

Manufacturer:	Sekisui Diagnostics
Device Type:	IVD, MULTIGENT Acetaminophen Reagent
Description:	IVD, Reagent, Test
Medical Device Identifier:	Cat. No. 2K99-20. Lot Number: 41928UQ11 Expiration Date: January 31,2013
Reason of Field Safety Corrective Action:	Discoloration of the Acetaminophen enzyme reagent (Rl) has been observed in some cartridges of Lot 41928UQ11. The discolored reagent generates a high calibration factor and erratic control recovery. Product tested during the investigation showed quality control results outside of expected ranges (> 3SD, both low and high).
Remedy Action:	Immediately discontinue use reagent and Destroy any remaining inventory of Lot 41928UQ11]
Athorized Representative/Importer/Distributor:	Medical supplies & Services Co.Ltd Mediserv, Riyadh, (01) 4780555
Report Source:	NCMDR
Source Ref. Number:	D93F17BBEB2D5
SFDA Comments:	SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:	No Attachments

View History