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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 02 17 000
Date submitted: 2/16/2017
Device Type:CELL‐DYN Ruby
Description: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.
Remedy Action: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.
Athorized Representative/Importer/Distributor:Medical supplies & Services Co.Ltd Mediserv
Report Source:NCMDR
Source Ref. Number:1FAF4069BB232
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Abbott Laboratories.pdf