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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 186 09 12 000
Date submitted: 9/30/2012
Manufacturer:Abbott Laboratories Inc
Device Type:Reagent, ARCHITECT HAVAb-IgG
Description:IVD, Reagent
Medical Device Identifier:List Numbers: 6C29-20 and 6C29-25 Lot Numbers: See Attachment
Reason of Field Safety Corrective Action:The ARCHITECT HAVAb-IgG assay shows a shift in the serum and plasma results to higher S/CO values over time, potentially leading to reduced specificity and increasedfalse reactive results.
Remedy Action:Refer to Attachment . Determine if you have any of the reagent lots listed in your inventory. Revise the expiration date for all reagent lots identified in your inventory per instructions of Attachment. After applying new expiration dates to reagent kits as listed in Attachment , discontinue use of those kits which are now outdated, and discard the material according to your laboratory procedures. Contact Abbott to order replacement material.
Athorized Representative/Importer/Distributor:Medical supplies & Services Co.Ltd Mediserv, Riyadh, (01) 4780555
Report Source:NCMDR
Source Ref. Number:8211EC8B6B275
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Abbott Laboratories Inc.pdf