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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 008 02 16 000
Date submitted: 2/4/2016
Manufacturer:Abbott Laboratories Inc
Device Type:ARCHITECT STAT High Sensitive Troponin-I Reagent Kit
Description: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.
Remedy Action:-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.
Athorized Representative/Importer/Distributor:Abbott Diagnostics Division
Report Source:NCMDR
Source Ref. Number:99281E4A1113A
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Abbott Laboratories.pdf