Source

SFDA- Saudi Food & Drug Authority.

https://ade.sfda.gov.sa/Fsca/PublishDetails/242

Product

ldylla™ Instrument

Manufacturer

Biocartis NV.

Local agent

Al Zahrawi Medical Supplies.

The affected products

REF: P00l0

UDI-DI: 05415219000119

Please refer to the attachment for details of production identifier.

Reason

It has been identified by Biocartis that false-positive MSI-H test results could be, or could have been, generated by the ldylla™ MSI Test at your laboratory for the affected Idylla™ Instruments.

Action

1. A service intervention for the affected Instrument(s) will be performed by A Biocartis representative.

2. Following an assessment of Idylla™ MSI Test run data for the affected lnstrument(s), a service intervention may be performed.

3. A Biocartis representative will contact you and provide details on when and how the (potential) service intervention will be performed.

4. Until your Instrument, listed in the attachment, is serviced, please move forward with the option that applies to your situation in the part Actions to be taken by the customer of the attachment.

5. Contact the local agent for remedial action.

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