Preview PRE-STA-25Recalls & reported problems
Wondfo USA CO., Ltd. · 25-Strip; Strep A Throat Swab Test · Class 1
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00816862023589), received between Jul 1, 2025 and Jul 1, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Off-Label Use” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Off-Label Use1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 1, 2025Off-Label Use; Off-Label Use
DEVICE WAS DISTRIBUTED THROUGH UNINTENDED CHANNELS TO END USERS NOT AUTHORIZED OR TRAINED TO USE THE PRODUCT - THE PRODUCT IS LABELED FOR PRESCRIPTION USE ONLY . ALTHOUGH NO ADVERSE EVENTS HAVE BEEN REPORTED, THIS MISDISTRIBUTION MAY PRESENT A RISK OF USE ERROR OR MISUSE. UPON BEING CONTACTED BY THE FDA ON 02 FEB 2024, IT WAS DECIDED BY WONDFO USA THAT A CORRECTIONS AND REMOVAL REPORT NEEDED TO BE FILED, THUS REPORT# 3007606081-04/19/24-001-R WAS FILED ON 19-APR-2024 TO REMOVE AFFECTED UNITS FROM THE MARKET. THIS MDR IS BEING SUBMITTED RETROSPECTIVELY FOLLOWING INTERNAL AUDIT REVIEW AND IN ALIGNMENT WITH POSTMARKET SURVEILLANCE AND FDA REPORTING OBLIGATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22378890 ↗
Other Antigens, All Groups, Streptococcus Spp. devices
- BD Veritor™ System for Rapid Detection of Group A Strep CLIA-Waived Kit 256040Becton, Dickinson And Company · ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP.258 reports
- Acceava® 92001Alere San Diego, Inc. · Antigens, All Groups, Streptococcus Spp.2 recalls2 reports
- QuickVue 20108Quidel Corporation · ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP.2 recalls0 reports
- Sofia 20274Quidel Corporation · ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP.1 recall2 reports
- Clearview® 92002Alere San Diego, Inc. · Antigens, All Groups, Streptococcus Spp.1 recall1 report
- McKesson 5003Mckesson Medical-Surgical Inc. · Antigens, All Groups, Streptococcus Spp.1 recall0 reports
- McKesson 4999Mckesson Medical-Surgical Inc. · Antigens, All Groups, Streptococcus Spp.1 recall0 reports
- QuickVue In-Line 00345Quidel Corporation · ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP.1 recall0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.