BD CTGCTV2 443979Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00382904439798), received between Dec 11, 2024 and Aug 21, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (3 reports).

1 other recall cover devices cleared under the same FDA submission (K210585); 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 16, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 21, 2026False Positive Result

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50379882 ↗
• MalfunctionMay 12, 2026False Negative Result

  IT WAS REPORTED THAT DURING USE OF BD MAX¿ CTGCTV2, A FALSE NEGATIVE CHLAMYDIA TRACHOMATIS (CT) PATIENT RESULT WAS OBTAINED. URINE SAMPLE WAS CT POSITIVE, HOWEVER, SWAB SAMPLE WAS CT NEGATIVE. UPON REPEAT TESTING ONCE WITH URINE AND TWICE WITH SWAB, ALL WERE CT POSITIVE. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25148827 ↗
• MalfunctionApr 14, 2026False Negative Result

  IT WAS REPORTED THAT DURING USE OF BD MAX¿ CTGCTV2, A FALSE NEGATIVE CHLAMYDIA TRACHOMATIS (CT) PATIENT RESULT WAS OBTAINED. URINE SAMPLE WAS CT POSITIVE; HOWEVER, SWAB SAMPLE WAS CT NEGATIVE. UPON REPEAT TESTING ONCE WITH URINE AND TWICE WITH SWAB, ALL WERE CT POSITIVE. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24872505 ↗
• MalfunctionMar 30, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING USE OF BD MAX¿ CTGCTV2, A DISCREPANT CHLAMYDIA TRACHOMATIS (CT) PATIENT RESULT WAS OBTAINED. SAMPLE INITIALLY TESTED CT POSITIVE. SAMPLE WAS THEN REPEATED AND WAS CT NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24716087 ↗
• MalfunctionJul 17, 2025False Positive Result; False Positive Result

  IT WAS REPORTED THAT DURING USE OF BD CTGCTV2 FOR BD MAX¿ SYSTEM, A TRICHOMONAS VAGINALIS FALSE POSITIVE PATIENT RESULT WAS OBTAINED. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22531884 ↗
• MalfunctionDec 11, 2024False Positive Result; False Positive Result

  IT WAS REPORTED THAT DURING USE OF BD CTGCTV2 ON BD MAX INSTRUMENT, 8 SAMPLES WERE FALSE POSITIVE FOR BOTH CHLAMYDIA TRACHOMATIS AND NEISSERIA GONORRHOEAE. AFTER INSPECTING THE REAGENTS AND INSTRUMENT, IT WAS VISIBLE THAT A "BLOODY SLIME STRING" FROM A SAMPLE WAS DRAGGED OVER THE PROCESS AREA AND CONTAMINATED THE SAMPLES. CLEANING AND ENVIRONMENTAL TESTING WERE PERFORMED. SAMPLES WERE RERUN AND WERE NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20902537 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K210585. One submission often covers many models, so check the product and lot details in each record.

• Z-0588-2025 · Oct 31, 2024 · Open, Classified
  BD COR MX Instrument Version or Model: 443989 Catalog Number: 443989