launching medical devices unique device identification (Saudi -DI) system and the Compliance timeframe
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2020-09-10
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The Saudi Food and Drug Authority (SFDA) has issued a field safety corrective action about "non- contact forehead - Infrared Thermometer IM-9001" due to inaccurate temperature measurements.
The device is manufactured by the Shenzhen Anbson Industries Co. Ltd.
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.