Quidel Corporation has recalled 22,470 units of its QuickVue Dipstick Strep A Tests because they may produce false positive results. The recall includes various test kit sizes (25-count and 50-count packs) used to detect Group A Streptococcal antigen. Healthcare facilities and laboratories should stop using the affected test kits immediately, as an incorrect result could lead to patients receiving unnecessary medical treatment. No injuries or incidents have been reported to date.
The test has a potential to incorrectly indicate a Strep A infection when none is present. This risk of a false positive result could lead to patients being prescribed unnecessary antibiotics or other treatments for an infection they do not have.
Manufacturer: Quidel Corporation
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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