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Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 001 05 12 000
Date submitted: 5/1/2012
Manufacturer:ThermoFisher Scientific
Device Type:Reagent, MULTIGENT Hemoglobin A1c Reagent
Description:Used in clinical laboratories for the quantitative in vitro measurement of percent HbA1c (HbA1c fraction) in human whole blood on the ARCHITECT cSystems and the AEROSET
System. The HbA1c assay is intended to aid in the monitoring of long-term blood glucose control and compliance in individuals with diabetes mellitus.
Medical Device Identifier:CATALOG NO.: 02K96-20; LOT NO.: All lots within expiry date
Reason of Field Safety Corrective Action:Whole blood samples (either fresh or frozen) for HbA1c testing are pre-treated with MULTIGENT Hemoglobin Denaturant. The pre-treated samples are placed on the ARCHITECT cSystems and tested for glycated hemoglobin (HbA1c) and Total Hemoglobin (THb) concentrations. According to the package insert, pretreated samples must be allowed to incubate for a minimum of 5 minutes at 15 to 30 °C prior to testing. Pretreated samples are stated to be stable for “up to 8 hours at 15 to 30 °C and up to 48 hours if stored at 2 to 8 °C”. However, recent studies have demonstrated that HbA1c measurements increase with time after the samples are pre-treated. Therefore, it is necessary to change the handling instructions for pre-treating samples for the MULTIGENT HbA1c assay. The investigation to determine root cause is ongoing.
Remedy Action:Make changes to your laboratory procedures for performing MULTIGENT HbA1c testing to implement the updated handling of pre-treated samples (see attached) .
Athorized Representative/Importer/Distributor:Ebrahim M. Al-Mana & Bros. Co. Ltd., Riyadh, (01) 4610733
Report Source:NCMDR
Source Ref. Number:161E61C8C4221
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: ThermoFisher.pdf