Source

SFDA- Saudi Food & Drug Authority

httgs://ade.sfda.gov.sa/Fsca/PublishDetails/250

Product

ROTEM sigma complete & ROTEM sigma complete + hep.

Manufacturer

Tern Innovations GmbH (Werfen).

Local agent

Muscat Pharmacy & Stores LLC.

The affected products

ROTEM sigma complete. - Part No.: 555501 - Lot No. : S221203

Reason

The FIBTEM C AS results obtained with the current IVDR version exhibited a bias from Reason measurements made with the previous IVDD version for a population within the Obstetric setting, leading to an adjustment in a bleeding management algorithm.

Action

The manufacturer instructs the customers to follow these actions:

1. Check if you have established a bleeding management algorithm for ROTEM sigma,

2. If yes, verify the established bleeding management algorithm for a potential impact due to the bias between the IVDD and the IVDR cartridges and take appropriate validation actions for your algorithm following your internal procedures.

3. Contact the local agent for remedial action.

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