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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 027 03 11 000
Date submitted: 3/7/2011
Device Type:CELL-DYN Emerald Cleaner
Description:Laboratory analyzers designed to determine the morphology of the blood and blood-forming cells
Medical Device Identifier:CELL-DYN Emerald Cleaner List Number 09H46-02 Lot Number 4349
Reason of Field Safety Corrective Action:Abbott has identified occurrences where the CELL-DYN Emerald analyzer generates out-of-range low RBC or low RBC and PLT parameters on multiple levels of Quality Control (QC) when using CELLDYN Emerald Cleaner Lot #4349. Not all customers are experiencing this issue.
Remedy Action:1. Determine what lot(s) of CELL-DYN Emerald Cleaner you have in inventory. 2. Run the Decontamination Procedure per Operator’s Manual Section 9-15 to 9-16. 3. Check the QC and follow any additional laboratory procedures. 4. Destroy any remaining quantity of Lot #4349 5. Complete the Customer Reply Form
Athorized Representative/Importer/Distributor:Abbott Diagnostics Division, Riyadh (01) 2917222
Report Source:NCMDR
Source Ref. Number:D9D43638BA2D5
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company
Attachments: FA04MAR2011_CR.pdf