Cepheid is recalling over 91,000 Xpert Xpress Strep A test kits because the included pipettes may fail to dispense enough liquid to provide a valid test result. This defect can lead to 'invalid' or 'no result' readings when testing for Strep A infections. The recall affects approximately 89,958 kits of the XPRSTREPA-10 model and 1,413 kits of the Xprstrepa-CE-10 model distributed worldwide. Consumers who have these kits should contact the manufacturer or their healthcare provider for guidance on how to obtain functioning testing supplies.
The faulty pipettes do not dispense the required sample volume into the test cartridge. This mechanism of failure prevents the diagnostic system from processing the sample correctly, which may lead to delayed diagnosis or the need for re-testing if the initial results are returned as invalid.
Manufacturer notification
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
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Sources: FDA iRES · Raw API Response
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