QuickVue 20108Recalls & reported problems

Quidel Corporation · QkVue Strep A Dpstk 50T · Class 1

2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports: 0
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 2

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

2 FDA recall records name this device's identifier, 2 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

Apr 6, 2026Open, Classified
Product has the potential for false positive results
Z-2169-2026 · Root cause: Under Investigation by firm · FDA record ↗
Jun 17, 2025Open, Classified
Dipstick strep A test has potential for false positive results.
Z-2545-2025 · Root cause: Under Investigation by firm · FDA record ↗

Device details

UDI-DI	`30014613201083`
Brand	QuickVue
Model	20108
Company	Quidel Corporation
Product code	GTY · ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP.
Class	Class 1
FDA submission	K011097
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Nov 24, 2025

Device type (GMDN): Beta-haemolytic Group A Streptococcus antigen IVD, kit, rapid ICT, clinical

A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of antigens from Group A beta-haemolytic Streptococcus bacteria in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.

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All ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP. devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.