Antigens, All Groups, Streptococcus Spp.
FDA adverse event reports and recall history for antigens, all groups, streptococcus spp. (product code GTY), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 369
- Deaths
- 5
- Injuries
- 27
- Malfunctions
- 335
Reports per year
Source: FDA adverse event reports by year received, 2009–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2026-05-12Open, ClassifiedUnder Investigation by firm
QuickVue Dipstick Strep A Test, 50T, REF 20108, antigens, all groups, streptococcus spp.
Product has the potential for false positive results
- 2026-03-12Open, ClassifiedNo Marketing Application
Wondfo Streptococcal A At-Home Self-Test. At-home test for group A beta-hemolytic streptococcal infection.
Product not cleared by the FDA.
- 2026-03-12Open, ClassifiedNo Marketing Application
Clearest Strep-A Cassette Test. Test to determine the presence of group A streptococci (Strep A) in throat swab samples.
Product not cleared by the FDA.
- 2026-03-12Open, ClassifiedNo Marketing Application
Brand Name: Bisaf Strep A Self-Test. Test for detection of group A streptococcal antigens in throat swabs.
Product not cleared by the FDA.
- 2025-09-10Open, ClassifiedUnder Investigation by firm
QuickVue: Dipstick Strep A Test: 50T, REF: 20108; 25T, REF: 20125; 50T, SCN, REF: 20108SC
Dipstick strep A test has potential for false positive results.
- 2025-08-18Open, ClassifiedProcess control
Clearview Strep A Exact II Dipstick Respiratory Kit, CLIA Waived. Catalog Number: 4581225020
Due to a classification error in the inventory management system, specific medical devices were shipped to customers that did not have the requisite license to purchase such devices.
- 2024-09-19Open, ClassifiedProcess control
Acceava Respiratory Strep A, CLIA Waived, Catalog Number 4580295008
Due to a classification error in our inventory management system, these medical devices were shipped to customers that did not have the requisite license to purchase such devices.
- 2024-06-07Open, ClassifiedNo Marketing Application
Preview Strep A, Streptococcal A rapid test kits, Part Numbers: a) PRE-STA-25, b) PRE-STA-A-10
Wondfo USA has identified unauthorized distribution of the Preview Strep A Test Kit. Unauthorized distribution of this device would include sales and distribution of this test for at-home use, non-prescription use, over-the-counter use, or direct-to-consumer customers.
- 2024-06-07Open, ClassifiedNo Marketing Application
Clarity and Clarity Diagnostics LLC, Streptococcal A rapid test kits, Labeled as: a) Clarity Strep A Rapid Test, Part Number CD-STP25, b) Clarity Diagnostics LLC, Clarity Strep A Rapid Test, Part Number CD-STP25V
Wondfo USA has identified unauthorized distribution of the Preview Strep A Test Kit. Unauthorized distribution of this device would include sales and distribution of this test for at-home use, non-prescription use, over-the-counter use, or direct-to-consumer customers.
- 2024-06-07Open, ClassifiedNo Marketing Application
Streptococcal A rapid test kits, labeled as: Easy Healthcare Corporation, Areta Strep A Swab Test and EASY at Home Medical LLC, Areta One Step Strep A Swab Test, Part Number ARST-100
Wondfo USA has identified unauthorized distribution of the Preview Strep A Test Kit. Unauthorized distribution of this device would include sales and distribution of this test for at-home use, non-prescription use, over-the-counter use, or direct-to-consumer customers.
Monitor antigens, all groups, streptococcus spp. automatically
DeviceWatch watches FDA adverse events and recalls for the products you care about, summarizes clinical narratives with AI and alerts you when a safety signal emerges.