BD Veritor™ System for Rapid Detection of Group A Strep CLIA-Waived Kit 256040Recalls & reported problems

Summary

The FDA's MAUDE database contains 258 adverse event reports that list this exact device (DI 00382902560401), received between Jan 29, 2021 and Sep 22, 2026 — classified as 17 injuries, 241 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (105 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 258 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2026False Negative Result

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50856444 ↗
• MalfunctionSep 22, 2026False Negative Result

  It was reported while using the BD Veritor¿ System for Rapid Detection of Group A Strep CLIA-Waived Kit, a negative result for Group A Strep was obtained on one (1) patient test cartridge from a Veritor analyzer. The customer then tested the patient using the StrepAim Test Kit, which provided a positive result for Group A Strep. A second specimen was also collected from the patient for repeat testing on a Veritor analyzer. The patient was symptomatic and treated based on their clinical presentation. There were no health impact or consequences reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50856442 ↗
• MalfunctionMay 21, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED WHILE USING THE BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF GROUP A STREP CLIA-WAIVED KIT, ONE (1) DISCREPANT GROUP A STREP PATIENT RESULT WAS ALLEGED. FROM THE INITIAL TESTING, A GROUP A STREP POSITIVE RESULT WAS OBTAINED FROM A VERITOR ANALYZER. HOWEVER, THE PHYSICIAN ORDERED A CULTURE WHICH PROVIDED A GROUP A STREP NEGATIVE RESULT. THE PATIENT WAS TREATED BASED ON THEIR CLINICAL PRESENTATION AND NO HEALTH IMPACT OR CONSEQUENCES WERE REPORTED. IT IS NOTED THE CUSTOMER WAS INFORMED THAT PER THE INSTRUCTIONS FOR USE, A GROUP A STREP NEGATIVE RESULT OBTAINED FROM A VERITOR ANALYZER SHOULD BE CONFIRMED BY CULTURE AND NOT A GROUP A STREP POSITIVE RESULT. THIS IS REPORT 3 OF 3.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25242076 ↗
• MalfunctionMay 21, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED WHILE USING THE BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF GROUP A STREP CLIA-WAIVED KIT, ONE (1) DISCREPANT GROUP A STREP PATIENT RESULT WAS ALLEGED. FROM THE INITIAL TESTING, A GROUP A STREP POSITIVE RESULT WAS OBTAINED FROM A VERITOR ANALYZER. HOWEVER, THE PHYSICIAN ORDERED A CULTURE WHICH PROVIDED A GROUP A STREP NEGATIVE RESULT. THE PATIENT WAS TREATED BASED ON THEIR CLINICAL PRESENTATION AND NO HEALTH IMPACT OR CONSEQUENCES WERE REPORTED. IT IS NOTED THE CUSTOMER WAS INFORMED THAT PER THE INSTRUCTIONS FOR USE, A GROUP A STREP NEGATIVE RESULT OBTAINED FROM A VERITOR ANALYZER SHOULD BE CONFIRMED BY CULTURE AND NOT A GROUP A STREP POSITIVE RESULT. THIS IS REPORT 2 OF 3.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25242074 ↗
• MalfunctionMay 21, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED WHILE USING THE BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF GROUP A STREP CLIA-WAIVED KIT, ONE (1) DISCREPANT GROUP A STREP PATIENT RESULT WAS ALLEGED. FROM THE INITIAL TESTING, A GROUP A STREP POSITIVE RESULT WAS OBTAINED FROM A VERITOR ANALYZER. HOWEVER, THE PHYSICIAN ORDERED A CULTURE WHICH PROVIDED A GROUP A STREP NEGATIVE RESULT. THE PATIENT WAS TREATED BASED ON THEIR CLINICAL PRESENTATION AND NO HEALTH IMPACT OR CONSEQUENCES WERE REPORTED. IT IS NOTED THE CUSTOMER WAS INFORMED THAT PER THE INSTRUCTIONS FOR USE, A GROUP A STREP NEGATIVE RESULT OBTAINED FROM A VERITOR ANALYZER SHOULD BE CONFIRMED BY CULTURE AND NOT A GROUP A STREP POSITIVE RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25240543 ↗
• MalfunctionMay 21, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED WHILE USING THE BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF GROUP A STREP CLIA-WAIVED KIT, ONE (1) DISCREPANT GROUP A STREP PATIENT RESULT WAS ALLEGED. FROM THE INITIAL TESTING, A GROUP A STREP POSITIVE RESULT WAS OBTAINED FROM A VERITOR ANALYZER. THE SAME TEST CARTRIDGE WAS THEN REINSERTED INTO A VERITOR ANALYZER AND A GROUP A STREP NEGATIVE RESULT WAS OBTAINED. THERE WAS NO REPORT OF CONFIRMATORY TESTING PERFORMED. THE PATIENT WAS TREATED BASED ON THEIR CLINICAL PRESENTATION AND NO HEALTH IMPACT OR CONSEQUENCES WERE REPORTED. IT SHOULD BE NOTED THE ACTION OF REINSERTING A USED TEST CARTRIDGE IS CONSIDERED OFF-LABEL USE OF THE PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25240537 ↗
• MalfunctionMar 3, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED WHILE USING THE BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF GROUP A STREP CLIA-WAIVED KIT, ONE (1) GROUP STREP A NEGATIVE PATIENT RESULT WAS OBTAINED FROM A VERITOR ANALYZER. THE SAME PATIENT TEST CARTRIDGE WAS RE-INSERTED BACK INTO A VERITOR ANALYZER AND A GROUP STREP A POSITIVE RESULT WAS OBTAINED. NO CONFIRMATORY TESTING WAS REPORTED. IT SHOULD BE NOTED THE ACTION OF REINSERTING A USED TEST CARTRIDGE IS CONSIDERED OFF-LABEL USE OF THE PRODUCT. THE PHYSICIAN TREATED THE PATIENT BASED ON SYMPTOMS AND NO HEALTH IMPACT OR CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24499882 ↗
• MalfunctionFeb 20, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED WHILE USING THE BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF GROUP A STREP CLIA-WAIVED KIT, ONE (1) NEGATIVE GROUP A STREP PATIENT RESULT WAS OBTAINED FROM A VERITOR ANALYZER. HOWEVER, THE USER QUESTIONED THE ANALYZER RESULT AFTER VISUALLY OBSERVING LINES ON THE TEST CARTRIDGE AND INTERPRETED THE LINES AS POSITIVE FOR GROUP A STREP. NO CONFIRMATORY OR REPEAT TESTING WERE PERFORMED. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED. IT SHOULD BE NOTED THE ACTION OF VISUAL INTERPRETATION OF A TEST CARTRIDGE IS CONSIDERED OFF-LABEL USE OF THE PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24406084 ↗
• MalfunctionFeb 20, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED WHILE USING THE BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF GROUP A STREP CLIA-WAIVED KIT, ONE (1) NEGATIVE GROUP A STREP PATIENT RESULT WAS OBTAINED FROM A VERITOR ANALYZER. HOWEVER, THE USER QUESTIONED THE ANALYZER RESULT AFTER VISUALLY OBSERVING LINES ON THE TEST CARTRIDGE AND INTERPRETED THE LINES AS POSITIVE FOR GROUP A STREP. NO CONFIRMATORY OR REPEAT TESTING WERE PERFORMED. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED. IT SHOULD BE NOTED THE ACTION OF VISUAL INTERPRETATION OF A TEST CARTRIDGE IS CONSIDERED OFF-LABEL USE OF THE PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24406076 ↗
• MalfunctionFeb 20, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED WHILE USING THE BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF GROUP A STREP CLIA-WAIVED KIT, ONE (1) NEGATIVE GROUP A STREP PATIENT RESULT WAS OBTAINED FROM A VERITOR ANALYZER. HOWEVER, THE USER QUESTIONED THE ANALYZER RESULT AFTER VISUALLY OBSERVING LINES ON THE TEST CARTRIDGE AND INTERPRETED THE LINES AS POSITIVE FOR GROUP A STREP. NO CONFIRMATORY OR REPEAT TESTING WERE PERFORMED. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED. IT SHOULD BE NOTED THE ACTION OF VISUAL INTERPRETATION OF A TEST CARTRIDGE IS CONSIDERED OFF-LABEL USE OF THE PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24406075 ↗
• MalfunctionFeb 10, 2026False Positive Result

  IT WAS REPORTED WHILE USING A BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF GROUP A STREP CLIA-WAIVED KIT, ONE (1) FALSE POSITIVE GROUP A STREP PATIENT RESULT WAS OBTAINED. UPON PERFORMING CULTURE TESTING, A NEGATIVE GROUP A STREP RESULT WAS OBTAINED. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED. THE CUSTOMER HAS NOT RESPONDED TO MULTIPLE FOLLOW UP ATTEMPTS BY BD FOR ADDITIONAL INFORMATION. THIS IS REPORT 46 OF 50.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24303324 ↗
• MalfunctionFeb 10, 2026False Positive Result

  IT WAS REPORTED WHILE USING A BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF GROUP A STREP CLIA-WAIVED KIT, ONE (1) FALSE POSITIVE GROUP A STREP PATIENT RESULT WAS OBTAINED. UPON PERFORMING CULTURE TESTING, A NEGATIVE GROUP A STREP RESULT WAS OBTAINED. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED. THE CUSTOMER HAS NOT RESPONDED TO MULTIPLE FOLLOW UP ATTEMPTS BY BD FOR ADDITIONAL INFORMATION. THIS IS REPORT 45 OF 50.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24303323 ↗
• MalfunctionFeb 10, 2026False Positive Result

  IT WAS REPORTED WHILE USING A BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF GROUP A STREP CLIA-WAIVED KIT, ONE (1) FALSE POSITIVE GROUP A STREP PATIENT RESULT WAS OBTAINED. UPON PERFORMING CULTURE TESTING, A NEGATIVE GROUP A STREP RESULT WAS OBTAINED. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED. THE CUSTOMER HAS NOT RESPONDED TO MULTIPLE FOLLOW UP ATTEMPTS BY BD FOR ADDITIONAL INFORMATION. THIS IS REPORT 42 OF 50.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24303322 ↗
• MalfunctionFeb 10, 2026False Positive Result

  IT WAS REPORTED WHILE USING A BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF GROUP A STREP CLIA-WAIVED KIT, ONE (1) FALSE POSITIVE GROUP A STREP PATIENT RESULT WAS OBTAINED. UPON PERFORMING CULTURE TESTING, A NEGATIVE GROUP A STREP RESULT WAS OBTAINED. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED. THE CUSTOMER HAS NOT RESPONDED TO MULTIPLE FOLLOW UP ATTEMPTS BY BD FOR ADDITIONAL INFORMATION. THIS IS REPORT 50 OF 50.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24303321 ↗
• MalfunctionFeb 10, 2026False Positive Result

  IT WAS REPORTED WHILE USING A BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF GROUP A STREP CLIA-WAIVED KIT, ONE (1) FALSE POSITIVE GROUP A STREP PATIENT RESULT WAS OBTAINED. UPON PERFORMING CULTURE TESTING, A NEGATIVE GROUP A STREP RESULT WAS OBTAINED. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED. THE CUSTOMER HAS NOT RESPONDED TO MULTIPLE FOLLOW UP ATTEMPTS BY BD FOR ADDITIONAL INFORMATION. THIS IS REPORT 48 OF 50.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24303320 ↗
• MalfunctionFeb 10, 2026False Positive Result

  IT WAS REPORTED WHILE USING A BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF GROUP A STREP CLIA-WAIVED KIT, ONE (1) FALSE POSITIVE GROUP A STREP PATIENT RESULT WAS OBTAINED. UPON PERFORMING CULTURE TESTING, A NEGATIVE GROUP A STREP RESULT WAS OBTAINED. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED. THE CUSTOMER HAS NOT RESPONDED TO MULTIPLE FOLLOW UP ATTEMPTS BY BD FOR ADDITIONAL INFORMATION. THIS IS REPORT 36 OF 50.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24303319 ↗
• MalfunctionFeb 10, 2026False Positive Result

  IT WAS REPORTED WHILE USING A BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF GROUP A STREP CLIA-WAIVED KIT, ONE (1) FALSE POSITIVE GROUP A STREP PATIENT RESULT WAS OBTAINED. UPON PERFORMING CULTURE TESTING, A NEGATIVE GROUP A STREP RESULT WAS OBTAINED. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED. THE CUSTOMER HAS NOT RESPONDED TO MULTIPLE FOLLOW UP ATTEMPTS BY BD FOR ADDITIONAL INFORMATION. THIS IS REPORT 39 OF 50.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24303318 ↗
• MalfunctionFeb 10, 2026False Positive Result

  IT WAS REPORTED WHILE USING A BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF GROUP A STREP CLIA-WAIVED KIT, ONE (1) FALSE POSITIVE GROUP A STREP PATIENT RESULT WAS OBTAINED. UPON PERFORMING CULTURE TESTING, A NEGATIVE GROUP A STREP RESULT WAS OBTAINED. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED. THE CUSTOMER HAS NOT RESPONDED TO MULTIPLE FOLLOW UP ATTEMPTS BY BD FOR ADDITIONAL INFORMATION. THIS IS REPORT 40 OF 50.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24303317 ↗
• MalfunctionFeb 10, 2026False Positive Result

  IT WAS REPORTED WHILE USING A BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF GROUP A STREP CLIA-WAIVED KIT, ONE (1) FALSE POSITIVE GROUP A STREP PATIENT RESULT WAS OBTAINED. UPON PERFORMING CULTURE TESTING, A NEGATIVE GROUP A STREP RESULT WAS OBTAINED. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED. THE CUSTOMER HAS NOT RESPONDED TO MULTIPLE FOLLOW UP ATTEMPTS BY BD FOR ADDITIONAL INFORMATION. THIS IS REPORT 44 OF 50.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24303316 ↗
• MalfunctionFeb 10, 2026False Positive Result

  IT WAS REPORTED WHILE USING A BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF GROUP A STREP CLIA-WAIVED KIT, ONE (1) FALSE POSITIVE GROUP A STREP PATIENT RESULT WAS OBTAINED. UPON PERFORMING CULTURE TESTING, A NEGATIVE GROUP A STREP RESULT WAS OBTAINED. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED. THE CUSTOMER HAS NOT RESPONDED TO MULTIPLE FOLLOW UP ATTEMPTS BY BD FOR ADDITIONAL INFORMATION. THIS IS REPORT 38 OF 50.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24303315 ↗
• MalfunctionFeb 10, 2026False Positive Result

  IT WAS REPORTED WHILE USING A BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF GROUP A STREP CLIA-WAIVED KIT, ONE (1) FALSE POSITIVE GROUP A STREP PATIENT RESULT WAS OBTAINED. UPON PERFORMING CULTURE TESTING, A NEGATIVE GROUP A STREP RESULT WAS OBTAINED. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED. THE CUSTOMER HAS NOT RESPONDED TO MULTIPLE FOLLOW UP ATTEMPTS BY BD FOR ADDITIONAL INFORMATION. THIS IS REPORT 47 OF 50.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24303314 ↗
• MalfunctionFeb 10, 2026False Positive Result

  IT WAS REPORTED WHILE USING A BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF GROUP A STREP CLIA-WAIVED KIT, ONE (1) FALSE POSITIVE GROUP A STREP PATIENT RESULT WAS OBTAINED. UPON PERFORMING CULTURE TESTING, A NEGATIVE GROUP A STREP RESULT WAS OBTAINED. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED. THE CUSTOMER HAS NOT RESPONDED TO MULTIPLE FOLLOW UP ATTEMPTS BY BD FOR ADDITIONAL INFORMATION. THIS IS REPORT 43 OF 50.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24303313 ↗
• MalfunctionFeb 10, 2026False Positive Result

  IT WAS REPORTED WHILE USING A BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF GROUP A STREP CLIA-WAIVED KIT, ONE (1) FALSE POSITIVE GROUP A STREP PATIENT RESULT WAS OBTAINED. UPON PERFORMING CULTURE TESTING, A NEGATIVE GROUP A STREP RESULT WAS OBTAINED. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED. THE CUSTOMER HAS NOT RESPONDED TO MULTIPLE FOLLOW UP ATTEMPTS BY BD FOR ADDITIONAL INFORMATION. THIS IS REPORT 37 OF 50.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24303311 ↗
• MalfunctionFeb 10, 2026False Positive Result

  IT WAS REPORTED WHILE USING A BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF GROUP A STREP CLIA-WAIVED KIT, ONE (1) FALSE POSITIVE GROUP A STREP PATIENT RESULT WAS OBTAINED. UPON PERFORMING CULTURE TESTING, A NEGATIVE GROUP A STREP RESULT WAS OBTAINED. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED. THE CUSTOMER HAS NOT RESPONDED TO MULTIPLE FOLLOW UP ATTEMPTS BY BD FOR ADDITIONAL INFORMATION. THIS IS REPORT 34 OF 50.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24303310 ↗
• MalfunctionFeb 10, 2026False Positive Result

  IT WAS REPORTED WHILE USING A BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF GROUP A STREP CLIA-WAIVED KIT, ONE (1) FALSE POSITIVE GROUP A STREP PATIENT RESULT WAS OBTAINED. UPON PERFORMING CULTURE TESTING, A NEGATIVE GROUP A STREP RESULT WAS OBTAINED. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED. THE CUSTOMER HAS NOT RESPONDED TO MULTIPLE FOLLOW UP ATTEMPTS BY BD FOR ADDITIONAL INFORMATION. THIS IS REPORT 41 OF 50.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24303309 ↗