BD MAX™ CT/GC/TV 442970Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00382904429706), received between Apr 30, 2021 and Aug 11, 2026 — classified as 1 injury, 19 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (12 reports).

1 FDA recall record name this device's identifier.

1 other recall cover devices cleared under the same FDA submission (K151589); 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.

Recalls naming this device

1. Jul 17, 2019Class IITerminated

   The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.

   Z-2331-2019 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 11, 2026False Positive Result

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50209939 ↗
• MalfunctionAug 11, 2026False Positive Result

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50209931 ↗
• MalfunctionDec 19, 2022False Positive Result; False Positive Result

  REPORT 2 OF 3. IT WAS REPORTED THAT BD MAX¿ CT/GC/TV FALSE POSITIVES OCCURRED. UPON RETESTING SAMPLE THEY CAME BACK NEGATIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: A FEW POSITIVE CHLAMYDIA¿S THEY THINK ARE A FALSE POSITIVE. WE TESTED THEM AND THEY ALL CAME BACK POSITIVE AND THE CURVES LOOKS GOOD ON OUR END BUT UPON RETESTING THEY WERE ALL NEGATIVE WITHOUT TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16010907 ↗
• MalfunctionDec 19, 2022False Positive Result; False Positive Result

  REPORT 1 OF 3: IT WAS REPORTED THAT BD MAX¿ CT/GC/TV FALSE POSITIVES OCCURRED. UPON RETESTING SAMPLE THEY CAME BACK NEGATIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: A FEW POSITIVE CHLAMYDIA¿S THEY THINK ARE A FALSE POSITIVE. WE TESTED THEM AND THEY ALL CAME BACK POSITIVE AND THE CURVES LOOKS GOOD ON OUR END BUT UPON RETESTING THEY WERE ALL NEGATIVE WITHOUT TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16010900 ↗
• MalfunctionDec 19, 2022False Positive Result; False Positive Result

  REPORT 3 OF 3: IT WAS REPORTED THAT BD MAX¿ CT/GC/TV FALSE POSITIVES OCCURRED. UPON RETESTING SAMPLE THEY CAME BACK NEGATIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: A FEW POSITIVE CHLAMYDIA¿S THEY THINK ARE A FALSE POSITIVE. WE TESTED THEM AND THEY ALL CAME BACK POSITIVE AND THE CURVES LOOKS GOOD ON OUR END BUT UPON RETESTING THEY WERE ALL NEGATIVE WITHOUT TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16010814 ↗
• MalfunctionNov 30, 2022False Positive Result; False Positive Result

  IT WAS REPORTED THAT WHILE USING THE BD MAX¿ CT/GC/TV THAT THERE WERE THAT THERE WERE FALSE POSITIVE RESULTS FOR THREE PATIENT SAMPLES ON THE CTGCTV ASSAY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ALLEGED FALSE POSITIVE RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15887003 ↗
• MalfunctionOct 18, 2022False Positive Result; False Positive Result

  IT WAS REPORTED THAT WHILE USING BD MAX¿ CT/GC/TV THE CUSTOMER GOT A FALSE POSITIVES FOR CHLAMYDIA. SAMPLE WAS RECOLLECTED AND RERUN AND CAME OUT NEGATIVE. NO PATIENT IMPACT WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER CLAIMS FALSE POS FOR CHALMYDIA FOR 2 PATIENT SAMPLES; 1-ST FALSE POS OBTAINED ON 10/03/2022, RUN # (B)(6); 2-ND FALSE POS OBTAINED ON 10/07/2022, RUN #( B)(6); BOTH SAMPLES WERE RE-COLLECTED AND RE-RUN, BOTH CAME OUT NEG; REPEATS WERE ORDERED BY THE DOCTOR; NO ERRONEOUS RESULTS WERE REPORTED, NO UNNECESSARY PATIENT TREATMENTS WERE ADMINISTERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15621688 ↗
• MalfunctionOct 18, 2022False Positive Result; False Positive Result

  IT WAS REPORTED THAT WHILE USING BD MAX¿ CT/GC/TV THE CUSTOMER GOT A FALSE POSITIVE FOR CHLAMYDIA. SAMPLE WAS RECOLLECTED AND RERUN AND CAME OUT NEGATIVE. NO PATIENT IMPACT WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER CLAIMS FALSE POS FOR CHLAMYDIA FOR 2 PATIENT SAMPLES; 1-ST FALSE POS OBTAINED ON (B)(6) 2022, RUN # 2626; 2-ND FALSE POS OBTAINED ON (B)(6) 2022, RUN #2631; BOTH SAMPLES WERE RE-COLLECTED AND RE-RUN, BOTH CAME OUT NEG; REPEATS WERE ORDERED BY THE DOCTOR; NO ERRONEOUS RESULTS WERE REPORTED, NO UNNECESSARY PATIENT TREATMENTS WERE ADMINISTERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15621642 ↗
• MalfunctionAug 4, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING BD MAX¿ CT/GC/TV, THAT THERE WERE DISCREPANT TV RESULTS FROM THE SAME PATIENT. THIS IS A REPORT FOR A SINGLE OCCURRENCE. THERE WERE NO FALSE RESULTS REPORTED OUT TO THE PATIENT OR THE CLINICIAN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTS THAT THEY PERFORMED BOTH THE CT/GC/TV PANEL AND VAGINAL PANEL FOR THE SAME PATIENTS AND THE TV RESULTS WERE DIFFERENT BETWEEN THE TWO ASSAYS. PER CUSTOMER, THEY HAD AT LEAST 6 INSTANCES WHERE PATIENT SAMPLES WERE COLLECTED FOR BOTH VAGINAL PANEL AND CT/GC/TV AND UPON TESTING, THE TV RESULT WAS POSITIVE FOR THE VAGINAL PANEL BUT NEGATIVE FOR THE CT/GC/TV ASSAY. ALL CT/GC/TV TESTS WERE DONE USING CT2310. THE VAGINAL PANEL TESTS WERE DONE USING CT1321. DISCUSSED THE POSSIBILITY OF LOD AND SPECIMEN COLLECTION AFFECTING RESULTS. CUSTOMER WILL COLLECTED SPECIMEN INFORMATION LIKE RUN NUMBER AND POSITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15166796 ↗
• MalfunctionJun 13, 2022False Positive Result; False Positive Result

  IT WAS REPORTED WHEN USING THE BD MAX¿ CT/GC/TV ASSAY ON THE BD MAX¿ INSTRUMENT A FALSE POSITIVE RESULT WAS PRODUCED. NO CONFIRMATORY TESTING WAS USED. THE TEST WAS REPEATED ON THE BD MAX. THERE WAS NO REPORT OF ADVERSE PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED BY THE CUSTOMER THAT THERE IS A FALSE POSITIVE. CUSTOMER IS REPORTING DISCREPANT RESULTS WHEN USING 442970, LOT #2025616. CUSTOMER STATES THE RESULTS WAS POSITIVE FOR GONORRHEA INITIALLY, THEN REPEATED TWICE - THE RESULT WAS NEGATIVE WITH EACH REPEAT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14681712 ↗
• MalfunctionMay 26, 2022False Negative Result; False Negative Result

  IT WAS REPORTED THAT WHILE TESTING WITH BD MAX¿ CT/GC/TV 20 FALSE NEGATIVE RESULTS FOR TV TARGET OCCURRED OVER 6 MONTH PERIOD. PAP SMEARS OBTAINED POSITIVE RESULTS FOR TV ON THE SAME SAMPLES. THERE IS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTED TO BD-MARKETING 20 FALSE NEGATIVE SPECIMENS FOR TV TARGET OVER A 6 MONTH PERIOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14518490 ↗
• MalfunctionMay 10, 2022False Negative Result; False Negative Result

  IT WAS REPORTED THAT WHILE USING BD MAX¿ CT/GC/TV A FALSE NEGATIVE RESULT WAS OBTAINED BY THE LABORATORY PERSONNEL. A REPEAT TEST WAS USED TO CONFIRM THE RESULTS. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE RESULT WAS GIVEN OUT NEGATIVE BY THE BD MAX. RESULT OF BD MAX WAS NOT TRUSTED AND CUSTOMER TRUSTED THE CURVE MORE - RESULT WAS GIVEN OUT POSITIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14350089 ↗
• MalfunctionOct 26, 2021False Negative Result; False Negative Result

  IT WAS REPORTED THAT WHILE USING BD MAX¿ CT/GC/TV FALSE NEGATIVE RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. THE SAMPLE WAS SENT TO A HOSPITAL TO CONFIRM THE RESULTS AS FALSE POSITIVES. THE CUSTOMER STATED RESULTS WERE NOT REPORTED OUT SO THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE CLIENT REPORTS A SAMPLE (TEST NO. (B)(6)) WITH SUSPECTED POSITIVE NEISSERIA GONORRHOEAE (GC+) WHICH THE BD MAX RETURNED AS NEGATIVE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12698821 ↗
• MalfunctionSep 2, 2021False Positive Result; False Positive Result

  IT WAS REPORTED THAT WHILE TESTING WITH BD MAX¿ CT/GC/TV 2 FALSE POSITIVE RESULTS WERE OBTAINED. RESULTS WERE NOT REPORTED AND THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTS 2 FALSE POSITIVE RESULTS FOR GC FOR CAT 442970.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12414869 ↗
• MalfunctionAug 18, 2021False Positive Result; False Positive Result

  IT WAS REPORTED THAT WHILE TESTING WITH BD MAX¿ CT/GC/TV THERE WERE 9 FALSE POSITIVE RESULTS OBTAINED FOR TRICHOMONAS VAGINALIS. REPEAT TESTING RESULTS WERE NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER OBTAINED 9 POS PATIENT RESULTS FOR TRICHOMONAS VAGINALIS ON SIDE B, REPEATED THE TEST - AGAIN ON SIDE B - AND ALL OF THE SAMPLES CAME NEGATIVE. CUSTOMER REPORTED THE RESULTS FROM THE REPEAT RUN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12339873 ↗
• InjuryJul 19, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING BD MAX¿ CT/GC/TV FALSE POSITIVE RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. THE PATIENT WAS SENT TO HOSPITAL AND A NEW CT/GC PCR WAS DONE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WOULD LIKE TO KNOW IF THE MENINGOCOCCAL MENINGITIDIS TESTS CAN GIVE A FALSE POSITIVE ON NEISSERIA GONORRHOEAE?"

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12193962 ↗
• MalfunctionJun 30, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  EVENT DESCRIPTION: IT WAS REPORTED THAT WHILE USING THE BD INSTRUMENT MAX CLINICAL A FALSE POSITIVE RESULT WAS OBTAINED BY THE LABORATORY PERSONNEL. A REPEAT TEST WAS USED TO CONFIRM THE RESULTS AS FALSE POSITIVES. THE CUSTOMER STATED RESULTS WERE NOT REPORTED OUT SO THERE WAS NO REPORT OF PATIENT IMPACT. ASSAY USED: BD MAX¿ CT/GC/TV. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. "CUSTOMER REPORTS THAT THEY PERFORMED BOTH THE CT/GC/TV PANEL AND VAGINAL PANEL FOR THE SAME PATIENTS AND THE TV RESULT WAS DIFFERENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12096944 ↗
• MalfunctionJun 30, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  EVENT DESCRIPTION: IT WAS REPORTED THAT WHILE USING THE BD INSTRUMENT MAX CLINICAL A FALSE POSITIVE RESULT WAS OBTAINED BY THE LABORATORY PERSONNEL. A REPEAT TEST WAS USED TO CONFIRM THE RESULTS AS FALSE POSITIVES. THE CUSTOMER STATED RESULTS WERE NOT REPORTED OUT SO THERE WAS NO REPORT OF PATIENT IMPACT. ASSAY USED: BD MAX¿ CT/GC/TV. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " CUSTOMER REPORTS THAT THEY PERFORMED BOTH THE CT/GC/TV PANEL AND VAGINAL PANEL FOR THE SAME PATIENTS AND THE TV RESULT WAS DIFFERENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12096942 ↗
• MalfunctionJun 1, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT WHILE USING A MIX OF PRODUCTS IN THE PACK WAS OBSERVED BY THE LABORATORY PERSONNEL. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IN THE KIT, INSTEAD OF HAVING 2 X EXTRACTION TUBES (B2), THEY ONLY HAVE ONE BAG. THE SECOND ONE BEING EXTRACTION TUBES FOR ENTERIC VIRAL PANEL (D4)."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11912741 ↗
• MalfunctionApr 30, 2021False Positive Result; False Positive Result

  IT WAS REPORTED WHILE USING BD MAX¿ CT/GC/TV A FALSE POSITIVE FOR GC WAS OBTAINED. SAMPLE WAS RECOLLECTED AND RETESTED AND THE RESULT WAS NEGATIVE. THERE WAS NO REPORT OF ADDITIONAL PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MAX CTGCTV DISCREPANT RESULT; REPORTED BY MAS ON INSTRUMENT INITIAL GC POSITIVE RESULT DISPUTED AND RECOLLECT SAMPLE RESULT WAS GC NEGATIVE POSITION A8 (ENDOCERVICAL PATIENT SAMPLE) -INITIAL RESULT CT NEG, GC POS, TV NEG; CUSTOMER STATES SAMPLE REPEATED AND ALL RESULTS MATCHED; POSITIVE GC RESULT REPORTED AND RESULT DISPUTED; RECOLLECTION OF ENDOCERVICAL SAMPLE FROM SAME PATIENT AND TESTED ON CT2112 WITH CTGCTV (LOT K58028237020211109), RUN 22 (4/1/2021), POSITION B3 ¿ RECOLLECT SAMPLE RESULTS ALL NEGATIVE FOR CT, GC, AND TV;

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11755580 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K151589. One submission often covers many models, so check the product and lot details in each record.

• Z-0394-2018 · Jul 18, 2017 · Terminated
  BD MAX" CT/GC/TV. Catalog Number(s): 443824,442970,443590 (RUO).for collection and transport of vaginal and endocervical swab specimens, in addition to the preservation of urine