Source

SFDA- Saudi Food & Drug Authority.

https://ade.sfda. gov.sa/Fsca/PublishDetails/241

Product

VITROS 3600, 5600 and XT 7600 Systems.

Manufacturer

Ortho Clinical Diagnostics Inc.

Local agent

Al Hashar Pharmacy L.L.C.

The affected products

Product Code:

6802413 - 6802915 - 6904001 - 6844461 - 6272222 - 6904003 - 6802783 - 6802914 - 6904000

Affected Assays:

All Micro Well Assays.

Please refer to the attachments for more details.

Reason

It has been identified MicroWell assay results have the potential to be reported without the Reagent Expired (RE) result code, even when the Signal Reagent (SR) pack is past the expiry date. This can occur when an SR pack exceeds the onboard expiry and/or the shelf expiration date.

Action

1. Do not use expired Signal Reagent packs. See the Questions & Answers section in the attachment for more details.

2. The issue will be corrected with the next software release.

3. Contact the local agent for remedial action.

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