MAUDE Adverse Event Report: GUANGZHOU WONDFO BIOTECH CO., LTD PREVIEW® STREP A TEST KIT; RAPID ANTIGEN TEST FOR GROUP A STREPTOCOCCUS

Catalog Number	PRE-STA-25; PRE-STA-10
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
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.

• Brand Name: PREVIEW® STREP A TEST KIT
• Common Device Name: RAPID ANTIGEN TEST FOR GROUP A STREPTOCOCCUS
• Manufacturer (Section D): GUANGZHOU WONDFO BIOTECH CO., LTD; no.8 lizhishan road; science city, huangpu ; CH
• MDR Report Key: 22378890
• Report Number: 3007606081-2025-00001
• Device Sequence Number: 8300786
• Product Code: GTY
• UDI-Device Identifier: 00816862023589
• UDI-Public: 00816862023589
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/01/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: PRE-STA-25; PRE-STA-10
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/02/2024
• Event Location: Other
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/01/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown