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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 017 06 12 000
Date submitted: 6/4/2012
Manufacturer:Abbott Laboratories Inc
Device Type:Reagent Kit, ARCHITECT CA 19-9XR
Description:IVD, Reagent Kit
Medical Device Identifier:List Number: 2K91-27, 2K91-20, 2K91-25 Lot Number: 08849M500, 08851M500, 08852M500, 08853M500, 10122M500, 10040M500
Reason of Field Safety Corrective Action:The purpose of this communication is to provide instructions on actions your laboratory must take regarding ARCHITECT CA 19-9XR reagent lots listed above. Abbott has confirmed that these six ARCHITECT CA 19-9XR reagent lots are demonstrating a shift up in patient results. Abbott Controls however do not detect the upward shift and will test within range.
Remedy Action:Immediately, discontinue use of and destroy any remaining inventory of the lots listed above according to your laboratory procedures. Patient results obtained with the lots listed above should be reviewed with the treating physician or healthcare provider to ensure they are aware of the potential analytical issue and can determine whether re-evaluation of the patient is necessary.
Athorized Representative/Importer/Distributor:Medical supplies & Services Co.Ltd Mediserv, Riyadh, (01) 4780555
Report Source:NCMDR
Source Ref. Number:6533700A5B16D
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:No Attachments