BD COR CTGCTV2 US 445435Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00382904454357), received between Mar 30, 2026 and Sep 29, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026False Positive Result

  It was reported that during use of BD COR CTGCTV2 US, a False Positive Neisseria gonorrhoeae (GC) patient result was obtained.First run on BD MAX Vaginal Panel and BD COR CTGCTV2 US was GC positive. Patient requested repeat testing.Second run on BD COR CTGCTV2 US was GC Negative.A separate sample from same patient was also run on ThermoFisher OpenArray¿ and was negative for GC.There was no report of patient impact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50932322 ↗
• MalfunctionApr 14, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING USE OF BD MAX¿ CTGCTV2, A TRICHOMONAS VAGINALIS (TV) DISCREPANT PATIENT RESULT WAS OBTAINED. INITIAL TEST WAS TV POSITIVE. REPEAT TEST WAS TV NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24871381 ↗
• MalfunctionApr 14, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING USE OF BD MAX¿ CTGCTV2, A TRICHOMONAS VAGINALIS (TV) DISCREPANT PATIENT RESULT WAS OBTAINED. INITIAL TEST WAS TV POSITIVE. REPEAT TEST WAS TV NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24871201 ↗
• MalfunctionMar 30, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING USE OF BD COR¿ CTGCTV2, A DISCREPANT CHLAMYDIA TRACHOMATIS (CT) PATIENT RESULT WAS OBTAINED. INITIAL URINE TEST WAS CT POSITIVE. ANOTHER URINE SAMPLE FROM THE SAME PATIENT WAS COLLECTED AND TESTED AND WAS CT NEGATIVE. A VAGINAL SWAB WAS ALSO COLLECTED FROM THE SAME PATIENT AND TESTED AND WAS CT NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24731115 ↗