التفاصيل - تيقظ

الرقم المرجعي

الشركة الصانعة

اسم الجهاز الطبي

الأجهزة المتأثرة

الممثل المعتمد

سبب المشكلة

الإجراء التصحيحي

1) Discontinue use and dispose all affected products in table A in the attachment.
2) For Bicarbonate OSR6x37/OSR6x90 lots in table B in the attachement, if elevated LDH levels are suspected, please assess results in conjunction with patient’s LDH values.
3) Share the content of this letter with your laboratory and/or Medical Director to evaluate the requirement for a retrospective review of Bicarbonate results for neonatal patients and patients with elevated LDH levels.

The Bicarbonate reagent IFU has been updated by Beckman Coulter to provide guidance to the customer that samples with elevated Lactate Dehydrogenase (LDH) may cause falsely increased bicarbonate results and that if elevated LDH levels are suspected, please assess results in conjunction with patient’s LDH values.

Manufacturer's Action: Instructions and Removal.

_________________________________________________________________________________________________________________________________________

Update Action: 

Additional information in relation to LDH concentrations based on the BEC LDH product code used. Please refer to the attachment for more information.

المرفقات

مسجل لدى هيئة الحكومة الرقمية برقم:

SA-10-10-25-1088