OraQuick HCV Rapid Antibody Test 3001-1521Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00608337000535), received between Feb 26, 2019 and Feb 26, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (1 report).

1 other recall cover devices cleared under the same FDA submission (P080027); they may or may not involve this specific model.

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.

• InjuryFeb 26, 2019Incorrect, Inadequate or Imprecise Result or Readings

  (B)(6) HEALTH ((B)(6)) WAS IDENTIFIED TO BE USING THE ORAQUICK HCV RAPID ANTIBODY TESTING KIT IN ORAL MANNER AND NOT BY RECOMMENDATIONS FROM THE MANUFACTURER FOR USE IN THE UNITED STATES, AND ONLY RECOMMENDS USING THE FINGERSTICK BLOOD COLLECTION METHOD. (B)(6) HAS STOPPED PERFORMING THE TEST UNTIL FURTHER NOTICE AND IS WORKING WITH THE (B)(6) DEPARTMENT OF HEALTH RELATED TO CONTACTING THE PATIENTS POTENTIALLY IMPACTED BY THIS, WHO RECEIVED A (B)(6) HCV RESULT. (B)(6) IS CONDUCTING THIS OUTREACH AND OFFERING BLOOD DRAWS AT THE HEALTH CENTER'S (B)(6) LOCATION TO ALL PATIENTS AT NO COST TO THE PATIENT. ALL STAFF ARE UNDERGOING TRAINING WITH THE MANUFACTURER AND A NEW COMPETENCY TEST IS BEING IDENTIFIED. THE MANUFACTURER PACKAGING IS IDENTICAL TO THE PACKAGING FOR THE KITS ALLOWED IN EU TO USE IN AN ORAL MANNER AND ALMOST IDENTICAL TO THE ORAQUICK HIV RAPID TESTING WHICH IS PERFORMED IN AN ORAL MANNER. THE ORASURE, ORAQUICK HCV TEST HAS BEEN USED AT (B)(6) SINCE AT LEAST 2015. WE ARE CURRENTLY IN OUTREACH WITH 622 PATIENTS IDENTIFIED TO HAVE RECEIVED (B)(6) RESULTS DURING THAT TIMEFRAME, REGARDLESS OF THE MANNER IN WHICH THE TEST WAS PERFORMED AS SOME OF THE STAFF MAY HAVE BEEN USING

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8374064 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P080027. One submission often covers many models, so check the product and lot details in each record.

• Z-1509-2016 · Jan 15, 2016 · Terminated
  OraQuick HCV Visual Reference Panel Intended to assist new operation in becoming proficient at reading specimens with antibody levels near the limit of detection of the device.