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Medical Devices Sector
قطاع الأجهزة الطبية
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
mdprc 058 02 17 000
Analyzers, Laboratory, Hematology, Cell Counting, Automated
Medical Device Identifier:
List Number: 08H67‐01
Multiple serial numbers of the affected device are provided in the attached FSN
Reason of Field Safety Corrective Action:
Abbott Hematology has become aware that the CELL‐DYN Ruby instrument at your facility has a printed circuit board assembly (PCBA) that may prematurely fail and result in the loss of vacuum/pressure.
1. Your Abbott service team will be contacting you to replace the PCBA Pump Relay Board on your impacted instrument(s) at no charge.
2. Ensure that you have a back‐up instrument or an alternative method of generating hematology patient results should the instrument become inoperable.
3. If you have forwarded the product listed above to other laboratories, please inform them of this Product Correction and provide to them a copy of this letter.
4. Please retain this letter for your laboratory records.
Medical supplies & Services Co.Ltd Mediserv
Source Ref. Number:
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Copyright © 2008 Saudi Food and Drug Authority. All rights reserved.