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Medical Devices Sector
قطاع الأجهزة الطبية
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NCMDR Recall
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Reference Number:
mdprc 019 09 12 000
Date submitted:
9/2/2012
Manufacturer:
Radiometer Medical
Device Type:
IVD, ABL800 and ABL700 with XPE analyzers
Description:
IVD, analyzer
Medical Device Identifier:
ABL800 and ABL700 with XPE with software versions below V6.13 and using the HL7 V2.5 communication protocol
Reason of Field Safety Corrective Action:
The patient result mix-up occurs if: • The communication line is interrupted or disconnected • Two or more patient results are queued for transmission • The communication is re-established and the analyzer transmits the results in the queue. In this situation the first result will be transmitted with the correct patient ID, whereas succeeding results in the queue will be appended to the first patient ID
Remedy Action:
Upgrade the software in ABL800 and ABL700 with XPE analyzers to V6.13
Athorized Representative/Importer/Distributor:
Salehiya Trading Est. , Riyadh , (01) 4633205
Report Source:
NCMDR
Source Ref. Number:
FEE16ADA7B39E
SFDA Comments:
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:
Radiometer Medical (2).pdf
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