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الخميس - صفر 27, 1447
مسجل لدى هيئة الحكومة الرقمية برقم:
20250728714
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EN
SA-22-08-24-568
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
BIOFIRE® FILMARRAY® 2.0 and TORCH System
الأجهزة المتأثرة
FILMARRAY TORCH MODULE BOX Reference numbers: HTFA-ASY-0003, HTFA-ASY-0003-W, HTFA-ASY-0003U FILMARRAY 2.0 INSTRUMENT Reference numbers: FLM2-ASY-0001, FLM2-ASY-0001-W Please refer to the attachment for serial numbers.
الممثل المعتمد
ALJEEL MEDICAL COMPANY
سبب المشكلة
It has been identified an issue with a subset of internal equipment used during the temperature calibration process on BIOFIRE instruments manufactured or serviced between May 2022 and May 2024. The investigation found that BIOFIRE instruments calibrated with the affected equipment may have higher reported melting temperatures (Tms).
الإجراء التصحيحي
Please utilize the attachment to determine which of your instruments are impacted. If your instrument is not on the impacted list, no action is required. You can continue to use your instrument in accordance with product labeling. If your instrument is on the impacted list, it needs to be returned to a BIOFIRE Service Center for recalibration; your local bioMérieux contact will reach out to you to coordinate the return of your impacted BIOFIRE instrument(s). In the meantime, please follow "Required actions" in the attachment.
المرفقات
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