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NCMDR Recall
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Reference Number:
mdprc 113 02 17 000
Date submitted:
2/28/2017
Manufacturer:
Roche Diagnostics Ltd
Device Type:
cobas e 602 module and cobas e 801 module used with cobas® 8000 modular analyzer series
Description:
In vitro diagnostic devices
Medical Device Identifier:
GMMI / Part No.: 05990378001, 07682913001
Reason of Field Safety Corrective Action:
Discrepant information between the previous versions 4.2.1 and 5.0 cobas® 8000 operator’s manuals (OM) for non-standard tubes (NSTs). The version 5.0 OM incorrectly states that 11 to 16 mm diameter NSTs may be used on cobas e 602 and cobas e 801 modules. However, only NST diameters of 13 to 16 mm are permitted on these modules.
Remedy Action:
Ensure that only tubes with a diameter of 13 to 16 mm are used on cobas e 602 and cobas e 801 modules.
Replace any available version 5.0 cobas® 8000 operator’s manual by the version 5.1 cobas® 8000 operator’s manual, which states the correct non-standard tube specifications.
Athorized Representative/Importer/Distributor:
FAROUK, MAAMOUN TAMER & COMPANY
Report Source:
NCMDR
Source Ref. Number:
8B7CC606AC27F
SFDA Comments:
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:
Roche Diagnostics Ltd.pdf
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