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السبت - جمادى الآخرة 1, 1447
مسجل لدى هيئة الحكومة الرقمية برقم:
20250728714
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SA-19-11-25-1153
التفاصيل
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الشركة الصانعة
اسم الجهاز الطبي
Elecsys Anti-TSHR assay
الأجهزة المتأثرة
BASIC UDI-DI/GMMI / Part No, Device Identifier (UDI): GMMI 08496633190 – for cobas e801 & 402 (E2G), UDI 7613336001239N GMMI 08496609190 – for cobas e411 & 60x (E1G), UDI 7613336001229 All lots; Note: only 3 lots (Lot 840177, Lot 840183, and Lot 874011) are available in the market which are not already expired.
الممثل المعتمد
Roche Diagnostics Saudi Arabia Limited
سبب المشكلة
Internal reviews by Roche have confirmed two problems with the Elecsys Anti-TSHR assay (a test often used to measure results around the 1.75 IU/L medical decision point): 1. Results may vary by Instrument Platform The test results for the same patient sample are coming out significantly different depending on which instrument is used: - On the cobas e 411 analyzer: Results are showing a higher reading (a "positive bias") than they should be, with the error being up to 60% around the 1.75 IU/L cutoff. - On the cobas e 801 and e 402 units: Results are showing a lower reading (a "negative bias") than they should be, with the error being up to approximately 50% around the 1.75 IU/L cutoff. 2. Results may vary by Calibrator Lot (on the cobas e 411) On the cobas e 411 analyzer specifically, the results also change significantly when different lots of the test's calibrator are used. This causes discrepancies of up to 35 % between calibrator lots.
الإجراء التصحيحي
Stop using the following lots of Elecsys Anti-TSHR assay and switch to the lots as indicated below: Affected System: cobas e 411 Affected lots (stop using): Lot 840177 New unaffected lots (switch to): Lot 906872 Affected System: cobas e 402, cobas e 801 Affected lots (stop using): Lot 840183 and Lot 874011 New unaffected lots (switch to): Lot 908953 Customers should follow their standard laboratory operating procedures to the review of previous results no general recommendations by Roche. Manufacturer's Action: Instructions and Removal.
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