التفاصيل - تيقظ

الرقم المرجعي

الشركة الصانعة

اسم الجهاز الطبي

الأجهزة المتأثرة

الممثل المعتمد

سبب المشكلة

الإجراء التصحيحي

- Immediately inspect your inventory for the specific catalog and lot numbers listed. It is recommended the clinical laboratory staff review and segregate the affected lots.

- Remove and discard the affected label insert with incorrect spectral overlap factor values included in the kit box prior to use.

- The wrong SOF (Spectral Over Factors) values can be corrected by entering the right SOF values provided in Appendix 1 of attachment.

- Ensure the right SOF values are entered in the flow cytometry instrument prior to sample acquisition.
• Appendix 1 of attachment shows the corrected spectral overlap factors for the affected product lot numbers.
• Follow the instructions in Appendix 2 of attachment for manual entry or to scan the barcodes provided in Appendix 3 of attachment to obtain the correct Spectral Over Factors (SOF) values.

- Customers who have not used the affected product may proceed to enter the SOF values shown in Appendix 1 of attachment.

- If the affected products have been fully or partially used and subjects' samples have been processed and acquired on an instrument with the incorrect SOF values, review the results. If the subjects’ sample is available, after entering the correct SOF values in the flow cytometry instrument, reacquire the sample(s).

- If the subject sample(s) is not available anymore, this may require the subject to return to collect an additional sample for testing purposes.

Manufacturer Action: Instructions.

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