BD ProbeTec™ Chlamydia trachomatis Qx Assay Gray Amp Reagent Pack 442959Recalls & reported problems
Becton, Dickinson And Company · BD ProbeTec™ Chlamydia trachomatis Qx Assay Gray Amp Reagent Pack · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 17
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00382904429591), received between May 3, 2021 and Feb 24, 2026 — classified as 17 malfunctions.
The most frequently reported specific device problem is “False Positive Result” (13 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.
Reports received per month
Most reported problems
Device problems
- False Positive Result13
- Incorrect, Inadequate or Imprecise Result or Readings4
Patient problems
- No Clinical Signs, Symptoms or Conditions17
Recent adverse event reports
The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 24, 2026False Positive Result
IT WAS REPORTED THAT DURING USE OF THE BD PROBETEC¿ CHLAMYDIA TRACHOMATIS QX ASSAY GRAY AMP REAGENT PACK, A FALSE POSITIVE PATIENT RESULT WAS OBTAINED. SAMPLES WAS RE-RUN ON BD VIPER¿ LT SYSTEM, BUT THE NEGATIVE CONTROL FAILED. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24433802 ↗MalfunctionFeb 24, 2026False Positive Result
IT WAS REPORTED THAT DURING USE OF THE BD PROBETEC¿ CHLAMYDIA TRACHOMATIS QX ASSAY GRAY AMP REAGENT PACK, A FALSE POSITIVE PATIENT RESULT WAS OBTAINED. SAMPLES WAS RE-RUN ON BD VIPER¿ LT SYSTEM, BUT THE NEGATIVE CONTROL FAILED. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24433801 ↗MalfunctionFeb 24, 2026False Positive Result
IT WAS REPORTED THAT DURING USE OF THE BD PROBETEC¿ CHLAMYDIA TRACHOMATIS QX ASSAY GRAY AMP REAGENT PACK, A FALSE POSITIVE PATIENT RESULT WAS OBTAINED. SAMPLES WAS RE-RUN ON BD VIPER¿ LT SYSTEM, BUT THE NEGATIVE CONTROL FAILED. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24433800 ↗MalfunctionFeb 24, 2026False Positive Result
IT WAS REPORTED THAT DURING USE OF THE BD PROBETEC¿ CHLAMYDIA TRACHOMATIS QX ASSAY GRAY AMP REAGENT PACK, A FALSE POSITIVE PATIENT RESULT WAS OBTAINED. SAMPLES WAS RE-RUN ON BD VIPER¿ LT SYSTEM, BUT THE NEGATIVE CONTROL FAILED. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24433797 ↗MalfunctionFeb 24, 2026False Positive Result
IT WAS REPORTED THAT DURING USE OF THE BD PROBETEC¿ CHLAMYDIA TRACHOMATIS QX ASSAY GRAY AMP REAGENT PACK, A FALSE POSITIVE PATIENT RESULT WAS OBTAINED. SAMPLES WAS RE-RUN ON BD VIPER¿ LT SYSTEM, BUT THE NEGATIVE CONTROL FAILED. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24433796 ↗MalfunctionFeb 24, 2026False Positive Result
IT WAS REPORTED THAT DURING USE OF THE BD PROBETEC¿ CHLAMYDIA TRACHOMATIS QX ASSAY GRAY AMP REAGENT PACK, A FALSE POSITIVE PATIENT RESULT WAS OBTAINED. SAMPLES WAS RE-RUN ON BD VIPER¿ LT SYSTEM, BUT THE NEGATIVE CONTROL FAILED. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24433795 ↗MalfunctionFeb 24, 2026False Positive Result
IT WAS REPORTED THAT DURING USE OF THE BD PROBETEC¿ CHLAMYDIA TRACHOMATIS QX ASSAY GRAY AMP REAGENT PACK, A FALSE POSITIVE PATIENT RESULT WAS OBTAINED. SAMPLES WAS RE-RUN ON BD VIPER¿ LT SYSTEM, BUT THE NEGATIVE CONTROL FAILED. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24433794 ↗MalfunctionFeb 24, 2026False Positive Result
IT WAS REPORTED THAT DURING USE OF THE BD PROBETEC¿ CHLAMYDIA TRACHOMATIS QX ASSAY GRAY AMP REAGENT PACK, A FALSE POSITIVE PATIENT RESULT WAS OBTAINED. SAMPLES WAS RE-RUN ON BD VIPER¿ LT SYSTEM, BUT THE NEGATIVE CONTROL FAILED. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24433793 ↗MalfunctionFeb 24, 2026False Positive Result
IT WAS REPORTED THAT DURING USE OF THE BD PROBETEC¿ CHLAMYDIA TRACHOMATIS QX ASSAY GRAY AMP REAGENT PACK, A FALSE POSITIVE PATIENT RESULT WAS OBTAINED. SAMPLES WAS RE-RUN ON BD VIPER¿ LT SYSTEM, BUT THE NEGATIVE CONTROL FAILED. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24433792 ↗MalfunctionFeb 24, 2026False Positive Result
IT WAS REPORTED THAT DURING USE OF THE BD PROBETEC¿ CHLAMYDIA TRACHOMATIS QX ASSAY GRAY AMP REAGENT PACK, A FALSE POSITIVE PATIENT RESULT WAS OBTAINED. SAMPLES WAS RE-RUN ON BD VIPER¿ LT SYSTEM, BUT THE NEGATIVE CONTROL FAILED. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24433791 ↗MalfunctionFeb 24, 2026False Positive Result
IT WAS REPORTED THAT DURING USE OF THE BD PROBETEC¿ CHLAMYDIA TRACHOMATIS QX ASSAY GRAY AMP REAGENT PACK, A FALSE POSITIVE PATIENT RESULT WAS OBTAINED. SAMPLES WAS RE-RUN ON BD VIPER¿ LT SYSTEM, BUT THE NEGATIVE CONTROL FAILED. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24433790 ↗MalfunctionFeb 24, 2026False Positive Result
IT WAS REPORTED THAT DURING USE OF THE BD PROBETEC¿ CHLAMYDIA TRACHOMATIS QX ASSAY GRAY AMP REAGENT PACK, A FALSE POSITIVE PATIENT RESULT WAS OBTAINED. SAMPLES WAS RE-RUN ON BD VIPER¿ LT SYSTEM, BUT THE NEGATIVE CONTROL FAILED. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24433789 ↗MalfunctionFeb 23, 2026False Positive Result
IT WAS REPORTED THAT DURING USE OF THE BD PROBETEC¿ CHLAMYDIA TRACHOMATIS QX ASSAY GRAY AMP REAGENT PACK, AN UNSPECIFIED NUMBER OF FALSE POSITIVE PATIENT RESULTS WERE OBTAINED. POSITIVE SAMPLES WERE RE-RAN ON BD VIPER¿ LT SYSTEM, BUT THE NEGATIVE CONTROL FAILED. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24415519 ↗MalfunctionApr 18, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
REPORT 3 OF 3 IT WAS REPORTED WHEN USING THE BD PROBETEC¿ CHLAMYDIA TRACHOMATIS (CT) QX ASSAY GRAY AMP REAGENT PACK, DISCREPANT RESULT REPRODUCIBILITY OCCURRED. IN BETWEEN THE 2ND AND 3RD RUNS, THE USER FOUND FERRIC OXIDE ON TOP OF THE EXTRACTION RACK AND THOROUGHLY CLEANED TO REMOVE ANY POSSIBLE CONTAMINATION. THE USER REPEATED THE AFFECTED SPECIMEN AGAIN AFTER CLEANING AND THE FINAL RESULT MATCHED THE INITIAL RESULT OF CT NEGATIVE. RESULTS WERE AS FOLLOWS: 1ST RUN (CT NEGATIVE), 2ND RUN (CT POSITIVE), AND 3RD RUN (CT NEGATIVE). THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19133369 ↗MalfunctionApr 18, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
REPORT 2 OF 3: IT WAS REPORTED WHEN USING THE BD PROBETEC¿ CHLAMYDIA TRACHOMATIS (CT) QX ASSAY GRAY AMP REAGENT PACK, DISCREPANT RESULT REPRODUCIBILITY OCCURRED. IN BETWEEN THE 2ND AND 3RD RUNS, THE USER FOUND FERRIC OXIDE ON TOP OF THE EXTRACTION RACK AND THOROUGHLY CLEANED TO REMOVE ANY POSSIBLE CONTAMINATION. THE USER REPEATED THE AFFECTED SPECIMEN AGAIN AFTER CLEANING AND THE FINAL RESULT MATCHED THE INITIAL RESULT OF CT POSITIVE. RESULTS WERE AS FOLLOWS: 1ST RUN (CT POSITIVE), 2ND RUN (CT NEGATIVE), AND 3RD RUN (CT POSITIVE). THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19133366 ↗MalfunctionApr 18, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
REPORT 1 OF 3 IT WAS REPORTED WHEN USING THE BD PROBETEC¿ CHLAMYDIA TRACHOMATIS (CT) QX ASSAY GRAY AMP REAGENT PACK, DISCREPANT RESULT REPRODUCIBILITY OCCURRED. IN BETWEEN THE 2ND AND 3RD RUNS, THE USER FOUND FERRIC OXIDE ON TOP OF THE EXTRACTION RACK AND THOROUGHLY CLEANED TO REMOVE ANY POSSIBLE CONTAMINATION. THE USER REPEATED THE AFFECTED SPECIMEN AGAIN AFTER CLEANING AND THE FINAL RESULT MATCHED THE INITIAL RESULT OF CT NEGATIVE. RESULTS WERE AS FOLLOWS: 1ST RUN (CT NEGATIVE), 2ND RUN (CT POSITIVE), AND 3RD RUN (CT NEGATIVE). THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19133363 ↗MalfunctionMay 3, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT WHILE USING BD PROBETEC¿ CHLAMYDIA TRACHOMATIS (CT) QX ASSAY GRAY AMP REAGENT PACK FALSE POSITIVE RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. A REPEAT TEST WAS USED TO CONFIRM THE RESULTS AS FALSE POSITIVES. 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: " THEY ARE VERY UNSURE ABOUT THE RESULTS OF THE LOW POSITIVES AND WANT AN EXPLANATION WHY SOME OF THEM BECOME NEGATIVE WHEN REPEATED. SOME INFO FROM THE LAB: 7-9% "WEAK POSITIVE" (FROM 125-900 RFU) PER WEEK WITH 3 RUNS. SERVICE WAS DONE ON FEBRUARY 24TH, THEY NOTICED ONCE THAT THE POSITIVE CONTROL WAS 1243, AND ON THE OTHER DAYS OVER 2000 RFU OTHERWISE RELATIVELY STABLE. ALL POS ARE REPEATED BECAUSE THEY DO NOT TRUST THE VIPER 100%, EVEN WITH SAMPLES THAT HAVE A VALUE OF 1800. FOR THE DIAGNOSIS THEY GIVE ALWAYS THE FIRST VALUE, THE REPETITION IS ONLY INTERNAL. THEY WANT TO KNOW WHY THE VALUES ALWAYS ¿FLUCTUATE¿ SO STRONGLY. IN SEPTEMBER THEY HAD A VERY UNPLEASANT CONVERSATION WITH A PATIENT WHO MEASURED POSITIVE FOR THE VIPER (APPROX. 250 RFU). THE PATIENT WENT TO ANOTHER LABORATORY AND HAD
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11761632 ↗
Other DNA PROBE, NUCLEIC ACID AMPLIFICATION, CHLAMYDIA devices
- cobas z 480 05200881001Roche Molecular Systems, Inc. · DNA PROBE, NUCLEIC ACID AMPLIFICATION, CHLAMYDIA1 recall0 reports
- BD CTGCTV2 443979Becton, Dickinson And Company · DNA PROBE, NUCLEIC ACID AMPLIFICATION, CHLAMYDIA6 reports
- cobas® PCR Media Uni Swab Sample Kit 07958030190Roche Molecular Systems, Inc. · DNA PROBE, NUCLEIC ACID AMPLIFICATION, CHLAMYDIA3 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page