Source

SFDA- Saudi Food & Drug Authority

https://ade.sfda.gov.sa/Fsca/PublishDetails/247

Product

Liquid Assayed Specific Protein Controls

Manufacturer

Randox Laboratories

Local agent

Mustafa Sultan Science & Industry Co. LLC.

The affected products

Catalogue Number: PS2682, PS2683, PS2684, PS10221 , PS10222 , PS 10223.

Reason

Randox have confirmed that the levels of Free Lambda Light Chains in our Liquid Assayed Specific Protein Controls will increase over the shelf life of the product. While this analyte will remain in the Liquid Assayed Specific Protein Controls, values and stability claims will no longer be quoted for this analyte for all lots.

Action

1. The IFUs have been updated and are available on www.randox.com. Please discard the old IFUs and download the updated IFUs

2. Contact the local agent for remedial action.

Comments

Healthcare professionals are encouraged to report any adverse events Suspected to be associated with the above device or any other medical device to Department of Medical Device Control through the E-mail: vigilance-md@moh.gov.om