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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 069 07 11 000
Date submitted: 7/18/2011
Manufacturer:Abbott Diagnostic International Ltd
Device Type:ARCHITECT C-Peptide Reagent
Description:Reagents, Immunoassay, Therapeutic Drug
Medical Device Identifier:ARCHITECT C-Peptide Reagent. List Number: 03L53-25, Lot Number: 03610K000, 00110L000, 01711A000, 01411B000, 00611E00 0
Reason of Field Safety Corrective Action:Abbott has confirmed that the C-Peptide lots listed above have the potential to generate falsely elevated results with certain patient samples and with non-Abbott Controls.Only certain patient samples will show a shift in results. The effect on results varies from sample to sample.
Remedy Action:• Discontinue use and destroy any remaining inventory of these lots according to your laboratory procedures. • If you have forwarded any kits of the lots above to other laboratories, please inform them of this Product Recall and provide a copy of this letter to them. • To continue C-Peptide testing at your laboratory, Abbott recommends that you identify an alternate method for testing patient samples.
Athorized Representative/Importer/Distributor:Medical supplies & Services Co.Ltd Mediserv. Riyadh (01) 4780555
Report Source:NCMDR
Source Ref. Number:401DEE58C4267
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company
Attachments: Immuno Assay Analyser.pdf