Source

SFDA- Saudi Food & Drug Authority

https://ade.sfda.gov.sa/Fsca/PublishDetails/231

Product

HemosIL Heparin Calibrators

Manufacturer

Werfen

Local agent

Muscat Pharmacy & Stores LLC.

The affected products

Part No. 0020300600

UDI-DI: 08426950472483

Please see Appendix A of the attachment for a list of in-date lots with corrected value assignments for the HEP CAL 2 and HEP CAL 3 levels.

Reason

The potential of heparin controls reporting low out of their assigned acceptance range with HemosIL Liquid Anti-Xa (Part Nos. 0020302600, 0020302602, 0020303600), leading to delays in patient testing.

Action

1. Please follow "Mandatory Customer Actions" in the attachment.

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@mob.gov.om