PREVIEW® STREP A TEST KIT

Description of Event or Problem

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.