HEALGEN COVID-19/FLU A&B AG COMBO RAPID TEST CASSETTE (SWAB)
Received Feb 23, 2026 · Event occurred Jan 28, 2026
Report 3009238284-2026-00002 · MDR key 24416081
Device
Generic name
Multi-analyte Respiratory Virus Antigen Detection Test
Manufacturer
Healgen Scientific LlcCatalog number
GCFC-525SA
Lot number
2407060EUA
Product problems
- False Negative Result
Patient
NA · Unknown
- Insufficient Information
Narrative
Additional Manufacturer Narrative
INVESTIGATION IS IN PROGRESS.
Description of Event or Problem
CUSTOMER REPORTED A POTENTIAL FALSE NAGATIVE RESULT. HOWEVER, CONFIRMATION TEST METHOD WAS NOT PROVIDED.
Description of Event or Problem
CUSTOMER REPORTED A POTENTIAL FALSE NAGATIVE RESULT. HOWEVER, CONFIRMATION TEST METHOD WAS NOT PROVIDED. BASED ON THE MANUFACTURER'S RETAINED SAMPLES TESTED, ALL THE QUALITY CONTROL TESTS WERE NORMAL.
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 ISSUES WERE 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.