Genabio COVID-19 Rapid Self-Test Kit RA9-E00302Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00196852953004), received between Jan 5, 2023 and Jan 5, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Discolored” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 5, 2023Material Discolored; Material Discolored

  ON (B)(6) 2022, A GENABIO DIAGNOSTICS CUSTOMER SUBMITTED A COMPLAINT VIA EMAIL INDICATING THAT THEY OPENED UP ONE OF THE GENABIO COVID TESTS AND DISCOVERED THAT THE SWAB WAS USED AND COVERED WITH BROWN STAINS. THEY CALLED OUR COMPANY TO REPORT THIS ON THE SAME DAY. THE LOT NUMBER PROVIDED BY THE CUSTOMER WAS US220925. A PICTURE OF THE SWAB WAS PROVIDED BY THE CUSTOMER (SEE ATTACHMENT). ON 16-DEC-2022 THE FDA INFORMED GENABIO DIAGNOSTICS THAT THE ISSUE HAD BEEN REPORTED TO THEM ON MEDWATCH REPORT NUMBER MW5113786.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16103832 ↗