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Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 026 02 17 000
Date submitted: 2/9/2017
Manufacturer:Roche Diagnostics Ltd
Device Type:Elecsys TSH assay and Elecsys PTH assay used on cobas e 602 module
Description:In vitro diagnostic devices
Medical Device Identifier:TSH (Lot No. 185522)
PTH (1-84) (Lot No. 185522)
GMMI / Part No:
- TSH (GMMI 11731459122)
- PTH (1-84) (GMMI 05608546190)
Reason of Field Safety Corrective Action:The use of lot number 185522 for TSH and PTH (1-84) on cobas e 602 module leads to inappropriate reagent kit information for TSH
Remedy Action:Please do not use Elecsys TSH assay lot 185522 in any cobas 8000 modular analyzer series configuration (which includes cobas e 602 module) where the Elecsys PTH (1-84) assay lot 185522 have been previously used. Please switch to the next available Elecsys TSH assay lots 189279 and 212491.
In case you have not used in the cobas 8000 modular analyzer series configuration (which includes cobas e 602 module) Elecsys PTH (1-84) assay lot 185522, you can use the Elecsys TSH assay lot 185522 without any restrictions.
If you are affected by the issue: If hyperthyroidism is excluded by measuring of TSH only, retesting of results 0.26 – 0.36 μIU/mL should be considered if clinical symptoms point to hyperthyroidism.
Athorized Representative/Importer/Distributor:FAROUK, MAAMOUN TAMER & COMPANY
Report Source:NCMDR
Source Ref. Number:7C515F999825D
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Roche Diagnostics.pdf