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QuickVue 20125Recalls & reported problems

Quidel Corporation · QkVue Strep A Dpstk 25T · Class 1

1 open recall names 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
1

Summary

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

1 FDA recall record name this device's identifier, 1 still open.

1 other recall cover devices cleared under the same FDA submission (K011097); they may or may not involve this specific model.

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

  1. 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 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K011097. One submission often covers many models, so check the product and lot details in each record.

  • Z-2169-2026 · Apr 6, 2026 · Open, Classified
    QuickVue Dipstick Strep A Test, 50T, REF 20108, antigens, all groups, streptococcus spp.

Other ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP. devices

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.