Fastep COV-S23010H2Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00810022630358), received between Oct 21, 2024 and Dec 5, 2024 — classified as 9 malfunctions.

The most frequently reported specific device problem is “False Negative Result” (5 reports).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 5, 2024False Negative Result; False Negative Result

  CUSTOMER FOUND THEY WERE TESTING NEGATIVE WITH THE FASTEP TESTS, BUT WAS TESTING POSITIVE WITH OTHER AT HOME COVID-19 RAPID TEST BRANDS.

  Patient problems: Insufficient Information

  MAUDE report 20858884 ↗
• MalfunctionNov 27, 2024False Negative Result; False Negative Result

  CUSTOMER PURCHASED THE FASTEP TESTS AND KEPT GETTING NEGATIVE RESULTS EVEN THOUGH THE LAB HAD ALREADY CONFIRMED A POSITIVE RESULT. DECIDED TO USE ANOTHER BRAND AND THE RESULTS FOR THOSE WERE POSITIVE AS EXPECTED.

  Patient problems: Insufficient Information

  MAUDE report 20798256 ↗
• MalfunctionNov 27, 2024False Negative Result; False Negative Result

  CUSTOMER USED THIS TEST A COUPLE TIMES AND ALL TIMES HER RESULTS WERE NEGATIVE WHEN OTHER BRANDS PROVIDED POSITIVE RESULTS

  Patient problems: Insufficient Information

  MAUDE report 20798181 ↗
• MalfunctionNov 14, 2024False Negative Result; False Negative Result

  CUSTOMER COMMENT: "TWICE THIS TEST WAS WRONG. AN EXPIRED TEST PICKED UP COVID BUT THIS AND ANOTHER TEST DIDN'T. HAD I NOT GONE TO THE DOCTOR "JUST IN CASE" I WOULD STILL THINK I'M NEGATIVE AND POSSIBLY INFECTING PEOPLE. 4 DIFFERENT TESTS, ALL NEGATIVE. ONE TEST AT THE DOCTOR, 2 HOURS LATER, POSITIVE. OBVIOUSLY INACCURATE."

  Patient problems: Insufficient Information

  MAUDE report 20690324 ↗
• MalfunctionNov 13, 2024False Negative Result; False Negative Result

  USER RECEIVED A POSITIVE TEST AT THE DOCTOR'S OFFICE AND DECIDED TO PURCHASE THESE TESTS TO CHECK PROGRESS OF INFECTION. ALL TESTS TAKEN AFTER DOCTORS OFFICE WERE NEGATIVE. USER DECIDED TO USE A DIFFERENT BRAND WHICH SHOWED POSITIVE RESULTS.

  Patient problems: Insufficient Information

  MAUDE report 20675795 ↗
• MalfunctionNov 13, 2024False Positive Result; False Positive Result

  USER TESTED POSITITVE ON OUR TEST AND NEGATIVE ON ANOTHER BRAND. USER USED THIS TEST ON A PERSON THAT WAS NOT SICK AND STILL RECEIVED A POSITIVE RESULT FOR THAT PERSON.

  Patient problems: Insufficient Information

  MAUDE report 20675792 ↗
• MalfunctionNov 7, 2024False Positive Result; False Positive Result

  PARENT HAS GIVEN FEEDBACK THAT THEIR PRESCHOOLER HAS FALSELY TESTED POSITIVE DURING TWO DIFFERENT PERIODS IN A MATTER OF 30 DAYS.

  Patient problems: Insufficient Information

  MAUDE report 20635475 ↗
• MalfunctionNov 7, 2024False Positive Result; False Positive Result

  USER TESTED POSITIVE FOR 10+ DAYS, BUT WHEN TESTED WITH OTHER BRANDS THEY TESTED NEGATIVE. TRIED TESTING AGAIN WITH FASTEP AND AGAIN, POSITIVE RESULT.

  Patient problems: Insufficient Information

  MAUDE report 20635411 ↗
• MalfunctionOct 21, 2024False Positive Result; False Positive Result

  FASTEP COVID RATS REF COV-S23010H2, LOT I2301009, MFG 2023-01-03, EXP 2025-01-02 OBTAINED FROM AMAZON APPEARED PRONE TO FALSE POSITIVES. BETWEEN (B)(6) 2024, POSITIVE RESULTS FROM FASTEP COVID RATS ((B)(6) 2024 FAINT, (B)(6) 2024 VIBRANT) COULD NOT BE REPLICATED WITH TESTS FROM OTHER VENDORS SUCH AS MEDSTAR RAPID PCR ((B)(6) 2024), ABBOTT BINAXNOW ((B)(6) 2024), BOSON ((B)(6) 2024), AND INBIOS ((B)(6) 2024). THESE FINDINGS SUGGEST THAT EITHER THE FASTEP TESTS IN QUESTION WERE EXCEPTIONALLY SENSITIVE COMPARED TO TESTS BY OTHER MANUFACTURERS, -OR- THAT THE FASTEP TESTS WERE MORE LIKELY TO PRODUCE FALSE POSITIVES FOR WHATEVER REASON. IF TEST RESULTS WERE FALSE, THEY DELAYED PROPER TREATMENT. MILD SYMPTOMS WERE EXPERIENCED DURING THIS TIME FRAME, INCLUDING A LOW FEVER, HEADACHES, SORE THROAT, CONGESTION NEAR THE NOSE AND EARS. THE CAUSE OF THE LOW FEVER WAS EXPLICITLY DISPUTED BY A DOCTOR; A SECOND DOCTOR HAD INCREASED THE DOSAGE OF AMITRIPTYLINE FROM 10MG TO 20MG DAILY DURING THIS TIME PERIOD SHORTLY BEFORE THE LOW FEVER, AND THAT MEDICATION COULD HAVE CAUSED THE BODY TO RETAIN MORE HEAT THAN NORMAL. TREATMENT FOR ONGOING ALLERGY ISSUES WAS PARTIALLY SUSPENDED DURING THIS TIME, WHICH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20494177 ↗