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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 058 04 12 000
Date submitted: 4/17/2012
Manufacturer:Abbott Laboratories Inc
Device Type:Reagents, ARCHITECT STAT Troponin-I
Medical Device Identifier:List Number 2K41-28, Lot 74264UN11
Reason of Field Safety Corrective Action:Explanation The purpose of this communication is to provide instructions on actions your laboratory must take regarding a single lot of ARCHITECT STAT Troponin-I reagent. This issue is specific for lot 74264UN11. Abbott has confirmed that ARCHITECT STAT Troponin-I, lot 74264UN11 is demonstrating a shift in expected results in some cases. This effect can vary from kit to kit. All levels of Abbott Controls will detect the shift. If controls are out of range, performing a recalibration will restore the controls in range and accurate results would be generated. As described in the ARCHITECT STAT Troponin-I package insert, it is recommended that each control level be tested once every 24 hours each day of use. An investigation is in process. Initial indications suggest that the issue is caused by depressed Relative Light Unit (RLU) values.
Remedy Action:Necessary Actions Determine if you are currently using and/or have inventory of lot 74264UN11. Discontinue use of and destroy any remaining inventory of this lot according to your laboratory procedures. If lot 74264UN11 is the only lot available
Athorized Representative/Importer/Distributor:Medical supplies & Services Co.Ltd Mediserv, Riyadh, (01) 4780555
Report Source:NCMDR
Source Ref. Number:B9FC72D82E32D
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Abbott Laboratories Inc.pdf