Quidel Corporation recalls QuickVue Dipstick Strep A Test

Product has the potential for false positive results

QuidelOrtho issued an URGENT PRODUCT CORRECTION NOTIFICATION to its consignees on 4/6/2026 via courier (FedEx). The notice explained the problem, impact to results, and requested the following: "REQUIRED ACTION " Discontinue using, render unusable, and discard your remaining inventory of the above listed lots of QuickVue Dipstick Strep A Test. " Review the content of this communication with your Medical Director and retain this letter for your laboratory. " Complete and return the enclosed Confirmation of Receipt form no later than April 13, 2026. Upon receipt of your completed Confirmation of Receipt form, QuidelOrtho will credit or replace your discarded inventory, as needed. " Please forward this notification if the affected product was distributed outside of your facility." For questions, contact: Technical Support team at 1-800-874-1517 or technicalsupport@quidelortho.com. Distributors were requested to perform the following: "REQUIRED ACTION " Send the enclosed Customer Letter and Confirmation of Receipt form to all customers who have been shipped the affected lots of QuickVue" Dipstick Strep A Test from your facility. " Complete and return the enclosed Distributor Confirmation of Receipt form no later than April 13, 2026. " Please forward this notification if the affected product was distributed outside of your facility."

• FDA enforcement recordOfficial FDA database entry for Z-2169-2026
• FDA 510(k) clearance · K011097The device's official FDA premarket clearance record
• FDA device classification · GTYOfficial FDA classification for this device type
• CFR regulation · 21 CFR 866.3740The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Quidel CorporationSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.