CorDx Tyfast ACT21001-25Recalls & reported problems
Coretests, Inc. · CorDx Tyfast Flu A/B & COVID-19 Multiplex Rapid Test POC · Class N
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00850042559635), received between Jun 28, 2024 and Nov 8, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “False Positive Result” (2 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- False Positive Result2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 8, 2024False Positive Result; False Positive Result
ON OCTOBER 10TH, A PROVIDER FROM (B)(6) RAISED A COMPLAINT REGARDING MULTIPLE FALSE POSITIVE RESULTS OBSERVED WHILE USING CORDX TYFAST FLU A/B & COVID-19 MULTIPLEX RAPID TEST POC TESTS. APPROXIMATELY HALF OF A BOX OF 25T TESTS FROM BATCH NUMBER US2429810 WAS USED. MULTIPLE TESTS SHOWED POSITIVE RESULTS FOR BOTH FLU A AND FLU B, EVEN IN ASYMPTOMATIC PATIENTS. SOME TESTS SHOWED SIMULTANEOUS POSITIVE RESULTS FOR FLU A/B AND COVID-19.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20638454 ↗MalfunctionJun 28, 2024False Positive Result; False Positive Result
ON (B)(6) 2024, CORDX INC. RECEIVED FEEDBACK FROM BDSC (DISTRIBUTOR), STATING THAT THERE WERE FALSE POSITIVE RESULTS REPORTED (FLU A AND FLU B) WITH CORDX TYFAST FLU A/B & COVID-19 MULTIPLEX RAPID TEST BY END USERS. END USERS PERFORMED RE-TEST USING ANOTHER MANUFACTURER TEST KITS AND THE RESULTS WERE NEGATIVE. THE ACTUAL DATE OF THE TESTING WAS NOT PROVIDED. NO IMAGES OR RAW DATA FOR THE TESTING RESULTS COULD BE SHARED WITH CORDX TO ASSESS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19631036 ↗
Other Covid-19 Multi-Analyte Antigen Device devices
- Sofia 20377Quidel Corporation · COVID-19 Multi-Analyte Antigen Device1 recall3,284 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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