iHealth ICO-3000Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 50856362005895), received between Feb 4, 2022 and Sep 13, 2023 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Component Missing” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 13, 2023

  I USED THE IHEALTH COVID-19 ANTIGEN RAPID TEST KIT, THAT I GOT FREE THROUGH THE GOVERNMENT, 5 TIMES IN TOTAL. THE FIRST TIME I USED ONE, IT WORKED FINE. AFTER THAT, THE OTHER 4 TIMES, THE SMALL VIAL OF LIQUID THAT HAD TO BE POURED INTO THE BIGGER VIAL DID NOT HAVE QUITE ENOUGH LIQUID TO REACH THE FIRST LINE. THE INSTRUCTIONS SAID THAT THE LIQUID MUST REACH THE FIRST LINE AND NOT BE HIGHER THAN THE SECOND LINE, OR THE RESULTS OF THE TEST MIGHT BE INVALID. DUE TO THE LIQUID NOT BEING ENOUGH TO REACH THE LINE, I HAD TO TAKE THE LIQUID FROM THE SECOND TEST THAT WAS IN THE BOX TO FILL THE VIAL ENOUGH TO MAKE THE TESTS VALID. THIS OF COURSE MADE THE SECOND TEST IN THE KIT UNUSABLE. THEREFORE, THE GOVERNMENT PAID FOR TWO TESTS BUT ONLY GOT ONE TEST THAT WAS USABLE. I THINK THIS WAS KIND OF A RIP-OFF OF THE GOVERNMENT. REFERENCE REPORT #MW5145585, #MW5145586, #MW5145587.

  Patient problems: Insufficient Information

  MAUDE report 17743607 ↗
• MalfunctionAug 19, 2022Incorrect, Inadequate or Imprecise Result or Readings

  IHEALTH RAPID COVID-19 AT HOME KIT. RECEIVED BOXES FROM TRUSTED PROVIDER (COUNTY LIBRARY). ONE BOX (TWO TESTS) PROVIDED "INCONCLUSIVE" RESULTS, TESTS DONE 4 HOURS APART; REPEATED TEST WITH DIFFERENT BOX, DIFFERENT LOT # (NEGATIVE RESULTS), SUBSEQUENT DAYS. WHEN TEST WAS REPEATED WITH BOXES FROM DIFFERENT LOT NUMBERS, ALL OTHERS WERE NEGATIVE. FDA SAFETY REPORT ID # (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15265426 ↗
• MalfunctionJul 20, 2022False Positive Result

  WE PERFORMED 2 SEPARATE TESTS USING THE IHEALTH MDEL ICO-3000 SELF TEST COVID-19 ANTIGEN RAPID TEST WITH THE SAME PERSON, ONE RESULT WAS POSITIVE AND THE SUBSEQUENT TEST WAS NEGATIVE. THE USE OF THIS PRODUCT GIVES THE USER LOW CONFIDENCE IN THE USE OF THE TEST KIT AND ITS RELIABILITY. FDA SAFETY REPORT ID # (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 15079466 ↗
• MalfunctionJun 14, 2022Product Quality Problem; Component Missing

  NO DILUENT/STERILE MEDIA PROVIDED TO CONDUCT TESTING FOR KITS, MULTIPLE PACKAGES. BRAND: IHEALTH MODEL: ICO-3001, LOT NO.(10): 223CO20214, EXP:2022-08-13. FDA SAFETY REPORT ID# (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14695020 ↗
• InjuryFeb 4, 2022Patient-Device Incompatibility

  SON ADMINISTERED IHEALTH COVID-19 ANTIGEN RAPID TEST. ELEVEN (11) MINUTES AFTER PUTTING SWAB IN NOSE HIS TONGUE SWELLED, FACE AND THROAT SWELLED. HTTPS://IHEALTHLABS.COM. FDA SAFETY REPORT ID # (B)(4).

  Patient problems: Swelling/ Edema

  MAUDE report 13471969 ↗