Source

SFDA- Saudi Food & Drug Authority.

httgs://ade.sfda.gov.sa/Fsca/PublishDetails/243

Product

HbA1c II Calibrator

Manufacturer

Randox Laboratories

Local agent

Mustafa Sultan Science & Industry Co. LLC.

The affected products

Catalogue Number: HA8124

Please refer to the attachment for more details.

Reason

It has been identified by Randox Laboratories that the HbA1c TI Calibrator Series HA8124 is running with a negative bias on QC's and Patient samples.

Action

1. Please refer to the table in the attachment for the updated calibrator targets.

2. Please discard all copies of the calibrator Instructions for use (IFU)s and download the updated IFUs from www.randox.com.

3. Review results generated in line with the clinical profile of the patient.

4. Discuss the contents of the attachment with your Medical Director

5. 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