Quidel Corporation recalls QuickVue: Dipstick Strep A Test: 50T

Dipstick strep A test has potential for false positive results.

On 6/17/2025, correction notices were mailed to customers who were asked to do the following: 1) Send the enclosed customer letter and Confirmation of Receipt form to customers who were shipped any of the affected lots of Strep A Test from your facility. 2) The response form asks customers to acknowledge they have discontinued distributing and discarded the affected lots of Strep A Test 3) Complete and return the Confirmation of Receipt form via email to RA-OCDUS-CONFIRMAD@QUIDELORTHO.COM If you have further questions, please contact the firm's Global Services Organization at 1-800-874-1517 or technicalsupport@quidelortho.com.

• FDA enforcement recordOfficial FDA database entry for Z-2545-2025
• 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.