Recall Z-2169-2026— Quidel Corporation

Name: FDA recall Z-2169-2026
Creator: U.S. Food and Drug Administration
Published: 2026-04-06

Class II · Ongoing

Class II FDA medical device recall by Quidel Corporation, initiated 2026-04-06. It names one FDA 510(k) clearance: K011097. Product: QuickVue Dipstick Strep A Test, 50T, REF 20108, antigens, all groups, streptococcus spp.. Reason: Product has the potential for false positive results.

Recalling firm: Quidel Corporation
Classification: Class II
Status: Ongoing
Initiated: 2026-04-06
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, antigens, all groups, streptococcus spp.

Reason for recall

Product has the potential for false positive results

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