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تسجيل جديد
الجمعة - رجب 27, 1447
مسجل لدى هيئة الحكومة الرقمية برقم:
20250728714
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أسئلة شائعة
تواصل معنا
EN
SA-14-01-26-1211
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
cobas pro Sample supply unit, cobas pro SSU and cobas pure sample supply unit
الأجهزة المتأثرة
BASIC UDI-DI/GMMI / Part No Device Identifier (UDI): 08464502001 UDI- 07613336158784 09324437001 UDI- 07613336158784 09031537001 UDI- 07613336220153 09793178001 UDI- 07613336220146 Production Identifier (Lot No./Serial No.): cobas pro Sample supply unit all serial numbers cobas pro SSU <4401-01 cobas pure sample supply unit <25V2-01 and <7574-01 SW Version cobas pro- SW <03-01, cobas pure-SW <01-04
الممثل المعتمد
Roche Diagnostics Saudi Arabia Limited
سبب المشكلة
A software malfunction has been identified on the cobas pro (c503) and cobas pure (c303) platforms affecting the Calibration Library. This defect allows the system to accept erroneous, non-monotonous calibrations for Spline-type assays. When an erroneous calibration is active, the instrument fails to calculate new values and instead repeats the last successfully calculated result from any Spline-type assay for all subsequent measurements, leading to identical and erroneous patient and QC results.
الإجراء التصحيحي
● Only use one reagent pack for the affected Spline-type assays per analytical unit; do not load standby reagent packs for the affected Spline assays. ● The issue can be detected by running at least two different levels of QC at the same time, although the User guide does not explicitly define the number of QC levels to be run. ● No general recommendations with respect to the review of previous results can be given by using the cobas c503/303 analytical units. Customers should follow their standard laboratory operating procedures. Any specific questions raised by the users should be addressed individually, considering all relevant clinical information. Manufacturer's action: Instructions.
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