Recall Z-2545-2025— Quidel Corporation

Name: FDA recall Z-2545-2025
Creator: U.S. Food and Drug Administration
Published: 2025-06-17

Class II · Ongoing

Class II FDA medical device recall by Quidel Corporation, initiated 2025-06-17. It names one FDA 510(k) clearance: K011097. Product: QuickVue: Dipstick Strep A Test: 50T, REF: 20108; 25T, REF: 20125; 50T, SCN, REF: 20108SC. Reason: Dipstick strep A test has potential for false positive results..

Recalling firm: Quidel Corporation
Classification: Class II
Status: Ongoing
Initiated: 2025-06-17
Firm location: San Diego, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K011097 — QUICKVUE DIPSTICK STREP AQuidel Corp.·cleared 2001-05-08

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

QuickVue: Dipstick Strep A Test: 50T, REF: 20108; 25T, REF: 20125; 50T, SCN, REF: 20108SC

Reason for recall

Dipstick strep A test has potential for false positive results.

Data sourced from openFDA. This site is unofficial and independent of the FDA.