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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 115 12 17 000
Date submitted: 12/26/2017
Device Type:Hemoglobin A1c (HbA1c) Reagent
Description:IVD Test Reagent/Kits, Hematology, Calibration, Hemoglobin
Medical Device Identifier:List Number (LN): 4P52‐21
Multiple Lot numbers of the affected device are provided in the attached FSN.
Reason of Field Safety Corrective Action:The purpose of this Product Correction letter is to inform you Fetal Hemoglobin (HbF)
interference occurs at a level lower than what is stated in the HbA1c reagent package insert.
Remedy Action:• Please review this letter with your Medical Director.
• Take the information above into consideration when using the HbA1c reagent 4P52‐21.
• Complete and return the Customer Reply Form.
• Please retain this letter for your laboratory records.
Athorized Representative/Importer/Distributor:Medical supplies & Services Co.Ltd Mediserv
Report Source:NCMDR
Source Ref. Number:2AD59343CA29F
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Abbott.pdf