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Medical Devices Sector
قطاع الأجهزة الطبية
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
mdprc 008 02 16 000
Abbott Laboratories Inc
ARCHITECT STAT High Sensitive Troponin-I Reagent Kit
IVD, Reagent for Stat HsTN I
Medical Device Identifier:
List Number 3P25-26 Lot Number 56940UI00
Reason of Field Safety Corrective Action:
Abbott has confirmed an increase in calibration failures when using lot 56940UI00. Replacement material is available.
-If You do NOT have an alternate reagent lot available in inventory and you have generated a valid calibration curve using lot 56940UI00
Then mmediately order a replacement reagent lot. Continue to use lot 56940UI00 and follow the recommended QC procedures in the Package Insert. Once you receive the replacement reagent lot, destroy any remaining inventory of reagent lot 56940UI00 according to your laboratory procedures.
-If You HAVE an alternate reagent lot available in inventory
Then Discontinue use of lot 56940UI00 immediately and switch to the alternate reagent lot. Destroy any remaining inventory of reagent lot 56940UI00 according to your laboratory procedures.
Abbott Diagnostics Division
Source Ref. Number:
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Copyright © 2008 Saudi Food and Drug Authority. All rights reserved.