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الخميس - صفر 27, 1447
مسجل لدى هيئة الحكومة الرقمية برقم:
20250728714
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SA-28-05-25-914
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
VITROS 4600 Chemistry System - VITROS 5600 Integrated System - VITROS XT 7600 Integrated System
الأجهزة المتأثرة
Affected System Name (Catalog Numbers): VITROS® 4600 Chemistry System - Refurbished (690 0440) VITROS® 4600 Chemistry System (680 2445) VITROS® 5600 Integrated System - Refurbished (680 2915) VITROS® 5600 Integrated System (680 2413) VITROS® XT 7600 Integrated System – Certified (627 2222) VITROS® XT 7600 Integrated System (684 4461) VITROS® 5600 Integrated System (China) (690 4001) VITROS® XT 7600 Integrated System (China) (690 4003) Software versions: SW V3.2 to SW V3.8.3. Please refer to the attachment for details.
الممثل المعتمد
Samir Trading and Marketing CJSC
سبب المشكلة
A software anomaly exists in the VITROS System software, may incorrectly allow use of VITROS® Diluent Packs identified as expired.
الإجراء التصحيحي
- To prevent this issue from occurring, the shelf expiration date must be entered when manually loading VITROS Diluent Packs on VITROS 4600/5600/XT 7600 Systems. - View the Reagent Management Supply 3 screen to check for any onboard VITROS Diluent Packs marked as expired, refer to the attachment for more details. This issue will be resolved in an upcoming software update by QuidelOrtho. Manufacturer Action: Instructions and correction.
المرفقات
عودة للقائمة
