EQUATE COVID-19 & FLU A/B ANTIGEN TEST
Received Dec 30, 2025 · Event occurred Dec 16, 2025
Report 3009238284-2025-00003 · MDR key 23930076
Device
Generic name
Multi-analyte Respiratory Virus Antigen Detection Test
Manufacturer
Healgen Scientific LlcCatalog number
CB-EQUATE-CASSETTE-COVID FLU A
Lot number
2509025DEN
Product problems
- False Negative Result
- False Negative Result
Patient
35 YR · Female
- Insufficient Information
- Insufficient Information
Narrative
Additional Manufacturer Narrative
THE MANUFACTURER HAS COMPLETED THE INVESTIGATION. RETAINED SAMPLES FROM THE AFFECTED LOT IN USE AT THE TIME OF THE REPORTED EVENT WERE EVALUATED. TESTING WAS PERFORMED IN ACCORDANCE WITH ESTABLISHED AND VALIDATED PROCEDURES, AND NO ANOMALIES OR IRREGULARITIES WERE OBSERVED. ALL TESTED DEVICES MET APPLICABLE ACCEPTANCE CRITERIA AND PERFORMED AS INTENDED. NO PRODUCT-RELATED ISSUE WAS IDENTIFIED. THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED BASED ON THE RESULTS OF THE INVESTIGATION. NOTE: THIS IS THE FINAL REPORT.
Description of Event or Problem
A CUSTOMER REPORTED A SUSPECTED FALSE NEGATIVE RESULT AFTER TESTING HERSELF AND HER MOTHER TWICE ON (B)(6) 2025) USING THE EQUATE COVID-19 & FLU A/B ANTIGEN TEST, WITH ALL RESULTS NEGATIVE FOR COVID AND FLU A/B. DUE TO PERSISTENT SYMPTOMS, SHE SOUGHT MEDICAL CARE ON (B)(6) 2025 AND REPORTED A POSITIVE COVID RESULT AT A HEALTHCARE PROVIDER'S OFFICE; HOWEVER, THE TEST METHOD USED BY THE PROVIDER WAS NOT CONFIRMED BY THE CUSTOMER.
Additional Manufacturer Narrative
INVESTIGATION IS IN PROGRESS.
Description of Event or Problem
A CUSTOMER REPORTED A SUSPECTED FALSE NEGATIVE RESULT AFTER TESTING HERSELF AND HER MOTHER TWICE ((B)(6) 2025) USING THE EQUATE COVID-19 & FLU A/B ANTIGEN TEST, WITH ALL RESULTS NEGATIVE FOR COVID AND FLU A/B. DUE TO PERSISTENT SYMPTOMS, SHE SOUGHT MEDICAL CARE ON (B)(6) 2025 AND REPORTED A POSITIVE COVID RESULT AT A HEALTHCARE PROVIDER'S OFFICE; HOWEVER, THE TEST METHOD USED BY THE PROVIDER WAS NOT CONFIRMED BY THE CUSTOMER.