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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 098 03 16 000
Date submitted: 3/13/2016
Manufacturer:Abbott
Device Type:ARCHITECT T-Uptake Calibrators
Description:IVD, Calibrators
Medical Device Identifier:List Number : 2K48-01

Lot Numbers : 614719, 650124, 697989
Reason of Field Safety Corrective Action:Abbott has identified a stability issue that may lead to controls out of range. The calibrator lot may not be able to be used due to this issue.
Remedy Action:-For CALIBRATOR lots 614719 and 650124 : Immediately destroy any remaining inventory and order replacement material.

-For CALIBRATOR lots 697989 : If You HAVE an alternate Calibrator lot available in inventory (other than Calibrator lots 614719 or 650124). Then Immediately discontinue use of Calibrator lot 697989 and switch to the alternate calibrator lot. Destroy any remaining inventory of Calibrator lot 697989 according to your laboratory procedures.

If You do NOT have an alternate Calibrator lot available in inventory. Then Immediately order a replacement Calibrator lot. You may continue to use Calibrator lot 697989 while following your current laboratory QC procedures.

Once you receive the replacement Calibrator lot, destroy any remaining inventory of Calibrator lot 697989 according to your laboratory procedures.
Athorized Representative/Importer/Distributor:Medical supplies & Services Co.Ltd Mediserv
Report Source:NCMDR
Source Ref. Number:490A92B37F217
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Abbott.pdf