FDA DeviceClass IINotable

FDA Recall: QuickVue Dipstick Strep A Test, 50T, REF 20108, antigens, all groups, streptococcus spp.

Date: 2026-05-20
Brand: Quidel Corporation
Category: Medical Device
FDA Class: Class II

Description

Product has the potential for false positive results

Hazard

Product has the potential for false positive results

Remedy

12279 units

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