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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 022 09 11 000
Date submitted: 9/5/2011
Manufacturer:Abbott Diagnostic International Ltd
Device Type:Reagents, Clinical Chemistry Alkaline Phosphatase
Description:IVD, Reagents
Medical Device Identifier:List Number: 7D55-21 LOT: 71628UN10. List Number: 7D55-31 LOTS: 62474UN10 & 08145UN11.
Reason of Field Safety Corrective Action:Abbott Diagnostics is recalling Clinical Chemistry Alkaline Phosphatase reagents due to particulate matter identified as a Cladosporium fungal species in some reagent cartridges.
Remedy Action:Discontinue use and destroy any remaining inventory of those lots. Order alternative lots of Clinical Chemistry Alkaline Phosphatase. Complete and return the enclosed Customer Reply form.
Athorized Representative/Importer/Distributor:Medical supplies & Services Co.Ltd Mediserv, Riyadh, (01) 4780555
Report Source:NCMDR
Source Ref. Number:1D8B07B0921F1
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Abbott Diagnostic International Ltd - FSN.pdf