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Medical Devices Sector
قطاع الأجهزة الطبية
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 091 11 12 000
Date submitted: 11/21/2012
Manufacturer:Abbott Laboratories Inc
Device Type:IVD, Clinical Chemistry Phenobarbital reagent
Description:IVD, Clinical Chemistry
Medical Device Identifier: List Number: 1E08 Lot Number: 52803UN12, 62299UN12, 85773UN12 Expiration Date: See attached
Reason of Field Safety Corrective Action:Abbott Diagnostics is recalling Clinical Chemistry Phenobarbital reagent due to imprecision issues which increase with the age of the reagent
Remedy Action: Determine if you are using or have inventory of Clinical Chemistry Phenobarbital reagent lots 62299UN12 or 85773UN12. Discontinue use and destroy any remaining inventory of those lots in accordance with your institution’s policies and procedures. Order replacement lot 27426UN12, which will expire 18 DEC 2012, and is the only lot currently available. Additional lots with reduced dating will be available in December and January. Please adjust your order accordingly. (See attched)
Athorized Representative/Importer/Distributor:Medical supplies & Services Co.Ltd Mediserv,Riyadh,(01) 2917222
Report Source:NCMDR
Source Ref. Number:3B34E7F8DA328
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Abbott Laboratories Inc.pdf