التفاصيل - تيقظ

الرقم المرجعي

الشركة الصانعة

اسم الجهاز الطبي

الأجهزة المتأثرة

الممثل المعتمد

سبب المشكلة

الإجراء التصحيحي

Please perform the instructions provided below:
• Customers that have calibrated using SETPOINT lot SP251033 or SP251043 should perform a calibration using a subsequent lot. Customers that have not calibrated using SETPOINT lot SP251033 or SP251043 do not need to perform additional calibration.
• Discontinue use of and discard the calibrator SETPOINT lots SP251033 and SP251043.
• If you experience this issue, you may request credit for SETpoint products from Siemens.
• Controls with PLT results that are within the expected assigned value ranges may continue to be used.
• Customers who observe PLT results that are consistently out of the expected assigned value ranges for the TESTpoint lots TP251035, TP252035, TP253035, TP251045, TP252045, TP253045 should discontinue use of and discard them and you may request credit for TESTpoint products from Siemens.
• 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 and forward this letter to those who may have received this product.

Manufacturer action: Instructions and removal.

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