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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 085 03 11 000
Date submitted: 3/21/2011
Manufacturer:Abbott Diagnostic International Ltd
Device Type:Shear Valve Assembly
Description:Hematology Analyser
Medical Device Identifier:Shear Valve Assembly, used on CELL-DYN 3200, CELL-DYN 3500, CELL-DYN 3700, and CELL-DYN Ruby analyzers. Part nb: 8921204902 & 8921167602
Reason of Field Safety Corrective Action:A nylon washer, used on the Shear Valve Assembly, may have an undersized outer diameter that can potentially get caught within an adjacent drive plate opening. This issue may not appear on all instruments. When the nylon washer gets caught, the analyzer will generate “Shear Valve Position” faults or “RBC Diluent Syringe Overpressure” SIMs.
Remedy Action:Please follow the procedure in the Operator’s Manual Section 10, review the letter and inform your Laboratory Manager of the pending action. Complete and return the Customer Reply Form.
Athorized Representative/Importer/Distributor:Medical supplies & Services Co.Ltd Mediserv. Riyadh (01) 4780555
Report Source:NCMDR
Source Ref. Number:F26A960E5D25D
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company
Attachments: FA15MAR2011_LTR_FSN.pdf