BD CTGCTV2 for BD MAX™ System 443904Recalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 00382904439040), received between Oct 4, 2022 and May 22, 2026 — classified as 35 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (23 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 35 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 22, 2026Incorrect, Inadequate or Imprecise Result or Readings

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25254223 ↗
• MalfunctionMay 19, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING USE OF BD MAX¿ CTGCTV2, A DISCREPANT TRICHOMONAS VAGINALIS (TV) PATIENT RESULT WAS OBTAINED. TV RESULT FROM THE SAME SWAB WAS NEGATIVE ON BD MAX¿ CTGCTV2, AND POSITIVE ON BD MAX¿ VAGINAL PANEL. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25218568 ↗
• MalfunctionApr 23, 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 RESULT WAS TV POSITIVE. TEST WAS REPEATED AND WAS TV NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24965773 ↗
• MalfunctionMar 19, 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. ON THE FIRST RUN, CT WAS NEGATIVE, BUT UPON REPEAT THE CT RESULT WAS POSITIVE. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24638166 ↗
• MalfunctionMar 6, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING USE OF BD MAX¿ CTGCTV2, A DISCREPANT CHLAMYDIA TRACHOMATIS PATIENT RESULT WAS OBTAINED. THE FIRST TEST WAS CHLAMYDIA TRACHOMATIS NEGATIVE. TEST WAS REPEATED FROM THE SAME SAMPLE TWICE AND WAS CHLAMYDIA TRACHOMATIS POSITIVE BOTH TIMES. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24533955 ↗
• MalfunctionMar 6, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING USE OF BD MAX¿ CTGCTV2 (US), A FALSE POSITIVE TRICHOMONAS VAGINALIS (TV) PATIENT RESULT WAS OBTAINED. SAMPLE WAS REPEATED ON BD MAX¿ VAGINAL PANEL, AND THE RESULT WAS TV NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24533760 ↗
• MalfunctionDec 17, 2025False Positive Result; False Positive Result

  IT WAS REPORTED THAT DURING USE OF BD MAX¿ CTGCTV2 (US), A FALSE POSITIVE GONORRHEA PATIENT RESULT WAS OBTAINED. SAMPLE WAS REPEATED ON BD MAX TWICE AND WAS NEGATIVE FOR BOTH. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23828493 ↗
• MalfunctionDec 3, 2025False Negative Result; False Negative Result

  IT WAS REPORTED THAT DURING USE OF BD MAX¿ CTGCTV2 (US), A FALSE NEGATIVE TRICHOMONAS VAGINALIS (TV) PATIENT RESULT WAS OBTAINED. SAMPLE TESTED TV POSITIVE ON BD MAX¿ VAGINAL PANEL AND TV NEGATIVE ON BD MAX¿ CTGCTV2. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23707202 ↗
• MalfunctionDec 3, 2025False Positive Result; False Positive Result

  IT WAS REPORTED THAT DURING USE OF BD MAX¿ CTGCTV2, A FALSE POSITIVE CHLAMYDIA AND TRICHOMONAS VAGINALIS (TV) PATIENT RESULT WAS OBTAINED. ORIGINAL PATIENT SAMPLE AND NEW COLLECTED PATIENT SAMPLE WERE THEN TESTED AND WERE BOTH TV NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23707085 ↗
• MalfunctionNov 24, 2025False Positive Result; False Positive Result

  IT WAS REPORTED THAT DURING USE OF BD MAX¿ CTGCTV2, A FALSE POSITIVE TRICHOMONAS VAGINALIS (TV) PATIENT RESULT WAS OBTAINED. SAMPLE WAS RETESTED ON BD MAX¿ CTGCTV2 AND THE RESULT WAS TV NEGATIVE. PATIENT SAMPLE WAS RECOLLECTED AND SENT TO QUEST FOR APTIMA SURESWAB TRICHOMONAS VAGINALIS TEST AND RESULT WAS TV NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23631250 ↗
• MalfunctionNov 13, 2025False Positive Result; False Positive Result

  IT WAS REPORTED THAT DURING USE OF BD MAX¿ CTGCTV2, A FALSE POSITIVE CHLAMYDIA PATIENT RESULT WAS OBTAINED. ORIGINAL AND RECOLLECTED PATIENT SAMPLE WERE THEN TESTED ON MAX AND BOTH WERE CHLAMYDIA NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23546773 ↗
• MalfunctionSep 3, 2025False Positive Result; False Positive Result

  IT WAS REPORTED THAT DURING USE OF BD CTGCTV2 FOR BD MAX¿ SYSTEM, A CHLAMYDIA TRACHOMATIS FALSE POSITIVE PATIENT RESULT WAS OBTAINED. TEST WAS REPEATED AND WAS CHLAMYDIA TRACHOMATIS NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22956928 ↗
• MalfunctionFeb 11, 2025False Positive Result; False Positive Result

  IT WAS REPORTED THAT DURING USE OF BD CTGCTV2 FOR BD MAX¿ SYSTEM, A FALSE POSITIVE CHLAMYDIA TRACHOMATIS PATIENT RESULT WAS OBTAINED. SAMPLE WAS REPEATED AND GAVE A CHLAMYDIA TRACHOMATIS NEGATIVE RESULT. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21356762 ↗
• MalfunctionSep 13, 2024False Positive Result; False Positive Result

  IT WAS REPORTED THAT DURING USE OF BD CTGCTV2, A FALSE POSITIVE CHLAMYDIA TRACHOMATIS PATIENT RESULT WAS OBTAINED. SAMPLE WAS RETESTED ON MAX AGAIN AND THE RESULT WAS NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20214082 ↗
• MalfunctionSep 11, 2024False Positive Result; False Positive Result

  IT WAS REPORTED THAT DURING USE OF BD CTGCTV2 FOR BD MAX¿ SYSTEM, A FALSE POSITIVE CHLAMYDIA TRACHOMATIS PATIENT RESULT WAS OBTAINED. THE TEST WAS REPEATED AND GAVE A CHLAMYDIA TRACHOMATIS NEGATIVE RESULT. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20193169 ↗
• MalfunctionApr 29, 2024False Positive Result; False Positive Result

  IT WAS REPORTED THAT WHILE TESTING WITH THE KIT BD MAX CTGCTV2 US, THERE WAS A FALSE POSITIVE RESULT FOR TRICHOMONAS. THE SAMPLE WAS RECOLLECTED AND THE TEST WAS REPEATED WITH A NEGATIVE RESULT. BOTH SAMPLES WERE REPEATED AGAIN WITH NEGATIVE RESULTS. SAMPLE RECOLLECTION OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19202269 ↗
• MalfunctionMar 15, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED WHILE USING THE KIT BD MAX CTGCTV2 US THE USER NOTED A MIX OF PRODUCT WITHIN THE KIT, ELEVEN (11) MASTER MIXES WERE LABELED WITH B7 INSTEAD OF D3. THE BARCODES LABELS ON THE MASTER MIX WOULD NOT SCAN WHEN LOADED ON THE INSTRUMENT. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18913981 ↗
• MalfunctionMar 1, 2024False Positive Result; False Positive Result

  IT WAS REPORTED THAT DURING USE WITH THE KIT BD MAX CTGCTV2 US, THERE WAS A FALSE POSITIVE RESULT FOR CHLAMYDIA. THE TEST WAS REPEATED WITH A NEGATIVE RESULT. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18822343 ↗
• MalfunctionDec 7, 2023False Positive Result; False Positive Result

  IT WAS REPORTED WHEN USING THE KIT BD MAX CTGCTV2 US THE USER RECEIVED A POSITIVE RESULT FOR TRICHOMONAS BUT UPON REPEAT A NEGATIVE RESULT WAS RECEIVED. THE NEGATIVE RESULT WAS ALSO RECEIVED IN A VAGINAL PANEL PERFORMED BY THE USER. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18285311 ↗
• MalfunctionOct 13, 2023Non Reproducible Results; Non Reproducible Results

  IT WAS REPORTED THAT WHILE USING KIT BD MAX CTGCTV2 US, DISCREPANT RESULT OCCURRED. THIS IS A REPORT OF ONE OCCURRENCE, NO REPORT OF ADVERSE OR INJURY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER PROBLEM: PATIENT DISPUTED THEIR POS RESULT FOR CTGCTV2, AND THE REPEAT TESTS WERE NEG. CUSTOMER REQUESTED INVESTIGATION OF THE DISCREPANCY. FIRST REPEAT: 10/04/2023; NEW SBT FROM THE SAME SPECIMEN VIAL; RUN # 1697 IN B-11 - NEG; SECOND REPEAT: 10/05/2023; SAME (INITIAL) SBT; RUN # 1699 IN B12 - NEG; RESULT WAS INITIALLY REPORTED AS POS, AND LATER CORRECTED TO NEG. ALL RUNS DONE FROM THE SAME REAGENTS LOT # 3137830.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17936167 ↗
• MalfunctionSep 18, 2023False Positive Result; False Positive Result

  IT WAS REPORTED THAT WHILE USING KIT BD MAX CTGCTV2 US THERE WAS A FALSE POSITIVE. EVENT 2 OF 2 THE FOLLOWING INFORMATION WAS REPORTED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT THERE¿S DISCREPANT RESULTS. CUSTOMER PROBLEM: REPORTED FALSE POSITIVE ON 2 DIFFERENT PATIENTS ON CT AND SECOND RUN WITH DIFFERENT COLLECTED SAMPLES WERE NEGATIVE ON (B)(6). ONE PATIENT RAN ON SIDE A AND ANOTHER PATIENT ON SIDE B. HAZARD, INJURY OR ERRONEOUS RESULTS? YES. HAZARD, INJURY OR ERRONEOUS RESULTS DETAILS DID A DEATH OCCUR? NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17763960 ↗
• MalfunctionSep 18, 2023False Positive Result; False Positive Result

  IT WAS REPORTED THAT WHILE USING KIT BD MAX CTGCTV2 US THERE WAS A FALSE POSITIVE. EVENT 1 OF 2. THE FOLLOWING INFORMATION WAS REPORTED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT THERE¿S DISCREPANT RESULTS. CUSTOMER PROBLEM: REPORTED FALSE POSITIVE ON 2 DIFFERENT PATIENTS ON CT AND SECOND RUN WITH DIFFERENT COLLECTED SAMPLES WERE NEGATIVE ON (B)(6). ONE PATIENT RAN ON SIDE A AND ANOTHER PATIENT ON SIDE B. HAZARD, INJURY OR ERRONEOUS RESULTS? YES. HAZARD, INJURY OR ERRONEOUS RESULTS DETAILS DID A DEATH OCCUR? NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17763959 ↗
• MalfunctionAug 18, 2023False Positive Result; False Positive Result

  IT WAS REPORTED THAT DURING TESTING WITH KIT BD MAX CTGCTV2 US A FALSE POSITIVE RESULT WAS OBTAINED. REPEAT TESTING WAS PERFORMED AND THE RESULT WAS NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT DISCREPANT RESULTS WHILE USING CAT 443904 LOT 3135908. CUSTOMER REPORTS SAME ISSUE AS WITH CASE (B)(4) . PER CUSTOMER, THE ISSUE IS WITH THE CTGCTV2 ASSAY. FOR THE ONE PATIENT, THE FIRST RUN THE CT WAS POSITIVE AND THE RE-RUN THE CT WAS NEGATIVE. THE SPECIMEN WAS VAGINAL SWAB.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17580715 ↗
• MalfunctionJun 13, 2023False Negative Result; False Negative Result

  IT WAS REPORTED THAT WHILE USING THE BD CTGCTV2 FOR BD MAX¿ SYSTEM (US THAT THERE WAS A FALSE NEGATIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTS FALSE NEGATIVE RESULTS WITH LOT#: 2151523. CUSTOMER REPORTS FN FOR TRICHOMONAS SP. RESULT WAS CORROBORATED BY GRAM STAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17117941 ↗
• MalfunctionJun 13, 2023False Negative Result; False Negative Result

  IT WAS REPORTED THAT WHILE USING THE BD CTGCTV2 FOR BD MAX¿ SYSTEM (US THAT THERE WAS A FALSE NEGATIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTS FALSE NEGATIVE RESULTS WITH LOT#: 2151523. CUSTOMER REPORTS FN FOR TRICHOMONAS SP. RESULT WAS CORROBORATED BY GRAM STAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17117939 ↗