Health Canada — Medical Devices · Canada · 2023-11-24 · Type II
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Reported risk: XPRSTREPA-CE-10 kits packaged with defective pipettes may cause failure to dispense an adequate volume of the patient sample to the test cartridge. If there is inadequate volume of patient sample being tested, the customer may receive an 'invalid' or 'no result' test results. Recall start date: April 24, 2023
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