BD ProbeTec™ Chlamydia trachomatis (CT) Qx Amplified DNA Assay 441126Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00382904411268), received between Jan 7, 2022 and Nov 6, 2023 — classified as 5 malfunctions.

The most frequently reported specific device problem is “False Negative Result” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 6, 2023False Negative Result; False Negative Result

  2 OF 3: IT WAS REPORTED THAT WHILE CUSTOMER WAS PERFORMING CROSS-PLATFORM TESTING WITH XTR AND MAX USING BD PROBETEC¿ CHLAMYDIA TRACHOMATIS (CT) QX AMPLIFIED DNA ASSAY REAGENT PACK, PATIENT SAMPLE WAS DISCREPANT ON XTR ONLY. THE RESULTS HAVE NOT BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18072771 ↗
• MalfunctionNov 6, 2023False Negative Result; False Negative Result

  3 OF 3: IT WAS REPORTED THAT WHILE CUSTOMER WAS PERFORMING CROSS-PLATFORM TESTING WITH XTR AND MAX USING BD PROBETEC¿ CHLAMYDIA TRACHOMATIS (CT) QX AMPLIFIED DNA ASSAY REAGENT PACK, PATIENT SAMPLE WAS DISCREPANT ON XTR ONLY. THE RESULTS HAVE NOT BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18072769 ↗
• MalfunctionNov 3, 2023False Negative Result; False Negative Result

  1 OF 3: IT WAS REPORTED THAT WHILE CUSTOMER WAS PERFORMING CROSS-PLATFORM TESTING WITH XTR AND MAX USING BD PROBETEC¿ CHLAMYDIA TRACHOMATIS (CT) QX AMPLIFIED DNA ASSAY REAGENT PACK, PATIENT SAMPLE WAS DISCREPANT ON XTR ONLY. THE RESULTS HAVE NOT BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18066890 ↗
• MalfunctionFeb 24, 2023False Positive Result; False Positive Result

  IT WAS REPORTED THAT BD PROBETEC¿ CHLAMYDIA TRACHOMATIS (CT) QX AMPLIFIED DNA ASSAY REAGENT PACK 1 PATIENT SAMPLE CAME BACK POSITIVE BUT WHEN RERUN TESTED NEGATIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 1 PATIENT SAMPLE WAS AFFECTED; DR. REQUESTED A RERUN, THE SAMPLE WAS NEG, REPORTED AS NEG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16436886 ↗
• MalfunctionJan 7, 2022False Positive Result; False Positive Result

  IT WAS REPORTED THAT WHILE USE WITH THE BD PROBETEC¿ CHLAMYDIA TRACHOMATIS (CT) QX AMPLIFIED DNA ASSAY REAGENT PACK, A (B)(6) RESULT WAS OBTAINED. REPEAT TESTING WAS PERFORMED, AND THE RESULTS WERE (B)(6). THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: POTENTIAL (B)(6). LAB RECEIVED SAMPLE FROM (B)(6) FOR (B)(6) TESTING, RAN ON VIPER AND REPORTED (B)(6) RESULT. PATIENT REFERRED TO (B)(6) CLINIC WHO TESTED AGAIN AND RESULTS CAME BACK (B)(6). LAB RE-TESTED THE ORIGINAL SAMPLES WHICH HAD BEEN STORED AND IT REPORTED A (B)(6) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13195064 ↗