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Warning Date
    2020-06-25
Manufacture Country

Switzerland

Manufacture Company

شركة LifeScan, Europe, GmbH

"SFDA" Issued a field safety notice on" OneTouch® Select Plus" Meter for Glucose Test Strips

2020-06-25

Saudi Food & Drug Authority (SFDA) has issued a field safety notice addressing a malfunction in a single batch of "OneTouch® Select Plus" glucose test strips, manufactured by LifeScan, GmbH,

The SFDA has explained that the defective test strip is (lot #4582205), this was because the meter repeats to request a blood sample without any test result.

SFDA advised the consumers who have the affected strips to contact the authorized representative " Saudi International Trading Company Ltd. (SITCO Pharma) " by toll-free number: 8002440266 or by Email: service@lifescanmea.com for free replacement of strips.  

SFDA has encouraged the consumers to report any incidents/adverse events or problems suspected to be relevant to the product or any other medical devices to SFDA call center 19999, or the National Center for Medical Devices Reporting or the Saudi Vigilance Center.

Medical Equipment
  • To report sector-related issues

  • Call Centre 19999


Other Warnings

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