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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 007 05 14 000
Date submitted: 5/5/2014
Manufacturer:Abbott
Device Type:Hemoglobin A1c (HbA1c) Calibrators
Description:IVD, Calibration of quantitative HbA1c affinity assays.
Medical Device Identifier:Product : Hemoglobin A1c (HbA1c) Calibrators
List Number (LN) : 4P52-02
Lot Number : 45063UQ12
Expiration Date : 15 DEC 2014
Reason of Field Safety Corrective Action:HbA1c Calibrators LN 4P52-02, lot 45063UQ12 may contain a value sheet for a different HbA1c calibrator lot.
Patient results could be falsely elevated up to an 8% difference due to the use of incorrect calibrator values.
Remedy Action: Before using HbA1c Calibrators lot 45063UQ12, verify that the value sheet lot number matches the calibrator bottle lot number.

If HbA1c Calibrators lot 45063UQ12 has already been utilized in your laboratory, verify the concentrations configured for this calibrator lot match the values Attached.

If these do not match, use the values attached when calibrating the HbA1c assay using calibrator lot 45063UQ12.

Follow your laboratory protocol regarding the need for reviewing previously reported patient results if incorrect calibrator values were used.

( Please see attached )
Athorized Representative/Importer/Distributor:Abbott Diagnostics Division, (012) 651-1077
Report Source:NCMDR
Source Ref. Number:392305109D10E
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Abbott.pdf