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الجمعة - ذو القعدة 11, 1446
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EN
SA-09-09-24-584
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
Atellica CI & IM Analyzers, ADVIA Centaur XP, XPT & CP Systems
الأجهزة المتأثرة
Assay (Siemens Material Number/Unique Device Identification, Kit Lot Number): Atellica IM CA 19-9 (50 Test) (10995490 / 00630414598178, 55974535 & 55975535) Atellica IM CA 19-9 (250 Test) (10995489 / 00630414598161, 55977535) ADVIA Centaur CA 19-9 (50 Test) (10491379 / 00630414574257, 55970535 & 55971535) ADVIA Centaur CA 19-9 (250 Test) (10491244 / 00630414574028, 55972535 & 55973535) Test Code: CA 19-9 Manufacturing Date: 14-Nov-2023 Expiration Date: 14-Sep-2024
الممثل المعتمد
ABDULREHMAN AL GOSAIBI GTB
سبب المشكلة
A positive bias for some samples around a concentration of 37 U/mL with the lots listed above as compared to the previous lot.
الإجراء التصحيحي
• Discontinue use of and discard the kit lots listed above, refer to the attachment for more information. • Please review the attachment with your Medical Director to determine the appropriate course of action, including for any previously generated results, if applicable. • Please retain the attachment with your laboratory records.
المرفقات
عودة للقائمة
