BD COR™ GX INSTRUMENT 443990Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00382904439903), received between Oct 16, 2023 and Apr 7, 2026 — classified as 22 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (14 reports).

1 FDA recall record name this device's identifier, 1 still open.

1 other recall cover devices cleared under the same FDA submission (P160037); 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. Oct 31, 2024Class IIOpen, Classified

   BD confirmed that product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of unauthorized access that may impact the confidentiality, integrity and/or availability of the relevant products and associated data.

   Z-0589-2025 · Root cause: Software design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 7, 2026False Positive Result

  IT WAS REPORTED AFTER USING BD COR¿ GX INSTRUMENT, THERE WAS ONE FALSE POSITIVE RESULT THAT OCCURRED. THE RESULT WAS REPORTED TO THE PHYSICIAN, BUT NO ADVERSE IMPACT OR INCORRECT TREATMENT WAS REPORTED REGARDING THE PATIENT OR USER. THE PATIENT WAS REQUESTED FOR A RECOLLECT OF SAMPLE. THIS IS REPORT 2 OF 2.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24801222 ↗
• MalfunctionApr 7, 2026False Positive Result

  IT WAS REPORTED AFTER USING BD COR¿ GX INSTRUMENT, THERE WERE TWO FALSE POSITIVE RESULTS THAT OCCURRED. THE RESULTS WERE REPORTED TO THE PHYSICIAN, BUT NO ADVERSE IMPACT OR INCORRECT TREATMENT WAS REPORTED REGARDING THE PATIENT OR USER. THE PATIENT WAS REQUESTED FOR A RECOLLECTION OF SAMPLE FOR RETESTING. THIS IS REPORT 2 OF 2.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24801221 ↗
• MalfunctionApr 7, 2026False Positive Result

  IT WAS REPORTED AFTER USING BD COR¿ GX INSTRUMENT, THERE WERE TWO FALSE POSITIVE RESULTS THAT OCCURRED. THE RESULTS WERE REPORTED TO THE PHYSICIAN, BUT NO ADVERSE IMPACT OR INCORRECT TREATMENT WAS REPORTED REGARDING THE PATIENT OR USER. THE PATIENT WAS REQUESTED FOR A RECOLLECTION OF SAMPLE FOR RETESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24800078 ↗
• MalfunctionApr 7, 2026False Positive Result

  IT WAS REPORTED AFTER USING BD COR¿ GX INSTRUMENT, THERE WAS ONE FALSE POSITIVE RESULT THAT OCCURRED. THE RESULT WAS REPORTED TO THE PHYSICIAN, BUT NO ADVERSE IMPACT OR INCORRECT TREATMENT WAS REPORTED REGARDING THE PATIENT OR USER. THE PATIENT WAS REQUESTED FOR A RECOLLECT OF SAMPLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24800072 ↗
• MalfunctionMar 30, 2026False Negative Result

  IT WAS REPORTED AFTER USING BD COR¿ GX INSTRUMENT, THERE WERE 3 POTENTIAL FALSE NEGATIVE RESULTS. THE CUSTOMER REPORTED THAT THE INSTRUMENT RESULTED 3 SAMPLES AS NEGATIVE BUT OBSERVED THAT THE CURVES FOR THESE SAMPLES WERE UNUSUAL AND SEEMED TO CROSS THE THRESHOLD. NORMAL BACTERIOLOGY RESULTS WERE THEN PERFORMED, BUT CUSTOMER STATED THAT ZERO SAMPLES WERE PROVEN TO HAVE FALSE RESULTS FROM CONFIRMATORY TESTING. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER. THIS IS REPORT 2 OF 3.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24713435 ↗
• MalfunctionMar 30, 2026False Negative Result

  IT WAS REPORTED AFTER USING BD COR¿ GX INSTRUMENT, THERE WERE 3 POTENTIAL FALSE NEGATIVE RESULTS. THE CUSTOMER REPORTED THAT THE INSTRUMENT RESULTED 3 SAMPLES AS NEGATIVE BUT OBSERVED THAT THE CURVES FOR THESE SAMPLES WERE UNUSUAL AND SEEMED TO CROSS THE THRESHOLD. NORMAL BACTERIOLOGY RESULTS WERE THEN PERFORMED, BUT CUSTOMER STATED THAT ZERO SAMPLES WERE PROVEN TO HAVE FALSE RESULTS FROM CONFIRMATORY TESTING. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER. THIS IS REPORT 3 OF 3.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24713136 ↗
• MalfunctionMar 26, 2026False Negative Result

  IT WAS REPORTED AFTER USING BD COR¿ GX INSTRUMENT, THERE WERE 3 POTENTIAL FALSE NEGATIVE RESULTS. THE CUSTOMER REPORTED THAT THE INSTRUMENT RESULTED 3 SAMPLES AS NEGATIVE BUT OBSERVED THAT THE CURVES FOR THESE SAMPLES WERE UNUSUAL AND SEEMED TO CROSS THE THRESHOLD. NORMAL BACTERIOLOGY RESULTS WERE THEN PERFORMED, BUT CUSTOMER STATED THAT ZERO SAMPLES WERE PROVEN TO HAVE FALSE RESULTS FROM CONFIRMATORY TESTING. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER. THIS IS REPORT 3 OF 3.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24703322 ↗
• MalfunctionMar 26, 2026False Negative Result

  IT WAS REPORTED AFTER USING BD COR¿ GX INSTRUMENT, THERE WERE 3 POTENTIAL FALSE NEGATIVE RESULTS. THE CUSTOMER REPORTED THAT THE INSTRUMENT RESULTED 3 SAMPLES AS NEGATIVE BUT OBSERVED THAT THE CURVES FOR THESE SAMPLES WERE UNUSUAL AND SEEMED TO CROSS THE THRESHOLD. NORMAL BACTERIOLOGY RESULTS WERE THEN PERFORMED, BUT CUSTOMER STATED THAT ZERO SAMPLES WERE PROVEN TO HAVE FALSE RESULTS FROM CONFIRMATORY TESTING. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER. THIS IS REPORT 2 OF 3.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24703315 ↗
• MalfunctionMar 26, 2026False Negative Result

  IT WAS REPORTED AFTER USING BD COR¿ GX INSTRUMENT, THERE WERE 3 POTENTIAL FALSE NEGATIVE RESULTS. THE CUSTOMER REPORTED THAT THE INSTRUMENT RESULTED 3 SAMPLES AS NEGATIVE BUT OBSERVED THAT THE CURVES FOR THESE SAMPLES WERE UNUSUAL AND SEEMED TO CROSS THE THRESHOLD. NORMAL BACTERIOLOGY RESULTS WERE THEN PERFORMED, BUT CUSTOMER STATED THAT ZERO SAMPLES WERE PROVEN TO HAVE FALSE RESULTS FROM CONFIRMATORY TESTING. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24699221 ↗
• MalfunctionMar 25, 2026False Negative Result

  IT WAS REPORTED AFTER USING BD COR¿ GX INSTRUMENT, THERE WERE 3 POTENTIAL FALSE NEGATIVE RESULTS. THE CUSTOMER REPORTED THAT THE INSTRUMENT RESULTED 3 SAMPLES AS NEGATIVE BUT OBSERVED THAT THE CURVES FOR THESE SAMPLES WERE UNUSUAL AND SEEMED TO CROSS THE THRESHOLD. NORMAL BACTERIOLOGY RESULTS WERE THEN PERFORMED, BUT CUSTOMER STATED THAT ZERO SAMPLES WERE PROVEN TO HAVE FALSE RESULTS FROM CONFIRMATORY TESTING. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24691052 ↗
• MalfunctionMar 13, 2026False Positive Result

  IT WAS REPORTED WHILE USING THE BD COR GX INSTRUMENT, THERE WERE 9 TOTAL FALSE POSITIVE RESULTS. THE INSTRUMENT EXPERIENCED CONTAMINATION FROM DUST AND DIRT PRESENT, LEADING TO THE FALSE POSITIVE RESULTS. NORMAL BACTERIOLOGY TESTING WAS PERFORMED TO CONFIRM THAT THESE WERE FALSE RESULTS. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.THIS IS REPORT 5 OF 9.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24598967 ↗
• MalfunctionMar 13, 2026False Positive Result

  IT WAS REPORTED WHILE USING THE BD COR GX INSTRUMENT, THERE WERE 9 TOTAL FALSE POSITIVE RESULTS. THE INSTRUMENT EXPERIENCED CONTAMINATION FROM DUST AND DIRT PRESENT, LEADING TO THE FALSE POSITIVE RESULTS. NORMAL BACTERIOLOGY TESTING WAS PERFORMED TO CONFIRM THAT THESE WERE FALSE RESULTS. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.THIS IS REPORT 9 OF 9.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24598938 ↗
• MalfunctionMar 13, 2026False Positive Result

  IT WAS REPORTED WHILE USING THE BD COR GX INSTRUMENT, THERE WERE 9 TOTAL FALSE POSITIVE RESULTS. THE INSTRUMENT EXPERIENCED CONTAMINATION FROM DUST AND DIRT PRESENT, LEADING TO THE FALSE POSITIVE RESULTS. NORMAL BACTERIOLOGY TESTING WAS PERFORMED TO CONFIRM THAT THESE WERE FALSE RESULTS. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.THIS IS REPORT 6 OF 9.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24598937 ↗
• MalfunctionMar 13, 2026False Positive Result

  IT WAS REPORTED WHILE USING THE BD COR GX INSTRUMENT, THERE WERE 9 TOTAL FALSE POSITIVE RESULTS. THE INSTRUMENT EXPERIENCED CONTAMINATION FROM DUST AND DIRT PRESENT, LEADING TO THE FALSE POSITIVE RESULTS. NORMAL BACTERIOLOGY TESTING WAS PERFORMED TO CONFIRM THAT THESE WERE FALSE RESULTS. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER. THIS IS REPORT 8 OF 9.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24595470 ↗
• MalfunctionMar 13, 2026False Positive Result

  IT WAS REPORTED WHILE USING THE BD COR GX INSTRUMENT, THERE WERE 9 TOTAL FALSE POSITIVE RESULTS. THE INSTRUMENT EXPERIENCED CONTAMINATION FROM DUST AND DIRT PRESENT, LEADING TO THE FALSE POSITIVE RESULTS. NORMAL BACTERIOLOGY TESTING WAS PERFORMED TO CONFIRM THAT THESE WERE FALSE RESULTS. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER. THIS IS REPORT 2 OF 9.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24595467 ↗
• MalfunctionMar 13, 2026False Positive Result

  IT WAS REPORTED WHILE USING THE BD COR GX INSTRUMENT, THERE WERE 9 TOTAL FALSE POSITIVE RESULTS. THE INSTRUMENT EXPERIENCED CONTAMINATION FROM DUST AND DIRT PRESENT, LEADING TO THE FALSE POSITIVE RESULTS. NORMAL BACTERIOLOGY TESTING WAS PERFORMED TO CONFIRM THAT THESE WERE FALSE RESULTS. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.THIS IS REPORT 4 OF 9.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24593808 ↗
• MalfunctionMar 13, 2026False Positive Result

  IT WAS REPORTED WHILE USING THE BD COR GX INSTRUMENT, THERE WERE 9 TOTAL FALSE POSITIVE RESULTS. THE INSTRUMENT EXPERIENCED CONTAMINATION FROM DUST AND DIRT PRESENT, LEADING TO THE FALSE POSITIVE RESULTS. NORMAL BACTERIOLOGY TESTING WAS PERFORMED TO CONFIRM THAT THESE WERE FALSE RESULTS. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER. THIS IS REPORT 3 OF 9.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24593807 ↗
• MalfunctionMar 13, 2026False Positive Result

  IT WAS REPORTED WHILE USING THE BD COR GX INSTRUMENT, THERE WERE 9 TOTAL FALSE POSITIVE RESULTS. THE INSTRUMENT EXPERIENCED CONTAMINATION FROM DUST AND DIRT PRESENT, LEADING TO THE FALSE POSITIVE RESULTS. NORMAL BACTERIOLOGY TESTING WAS PERFORMED TO CONFIRM THAT THESE WERE FALSE RESULTS. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.THIS IS REPORT 7 OF 9.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24593803 ↗
• MalfunctionMar 13, 2026False Positive Result

  IT WAS REPORTED WHILE USING THE BD COR GX INSTRUMENT, THERE WERE 9 TOTAL FALSE POSITIVE RESULTS. THE INSTRUMENT EXPERIENCED CONTAMINATION FROM DUST AND DIRT PRESENT, LEADING TO THE FALSE POSITIVE RESULTS. NORMAL BACTERIOLOGY TESTING WAS PERFORMED TO CONFIRM THAT THESE WERE FALSE RESULTS. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24589630 ↗
• MalfunctionAug 15, 2025False Negative Result; No Device Output; False Negative Result; No Device Output

  IT WAS REPORTED THAT DURING USE OF THE BD COR GX INSTRUMENT, "RESULTS DON'T MATCH" ON A CLINICAL SAMPLE. HPV-16 WAS DETECTED WITH OTHER TARGETS "INDETERMINATE" AND "UNDETECTABLE." A CONFIRMATION TEST WAS THEN PERFORMED AND HPV-51 WAS ALSO DETECTED. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22815366 ↗
• MalfunctionJun 17, 2025False Positive Result; False Positive Result

  IT WAS REPORTED WHILE USING BD COR GX INSTRUMENT, THERE WAS A FALSE POSITIVE RESULT FOR HPV FOR ONE PATIENT. REPEAT TESTING WAS PERFORMED ON THE COR GX AND INDICATED THAT THE RESULT WAS NEGATIVE. THE SAME SAMPLE ALSO UNDERWENT CONFIRMATORY TESTING ON VIPER LT INSTRUMENT AND THE RESULT WAS NEGATIVE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22236663 ↗
• MalfunctionOct 16, 2023False Negative Result; False Negative Result

  IT WAS REPORTED THAT WHILE USING BD COR GX INSTRUMENT HAS DOUBT ON RESULT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: HAZARD, INJURY OR ERRONEOUS RESULTS? NO. HAZARD, INJURY OR ERRONEOUS RESULTS DETAILS THE CUSTOMER ALWAYS LOOKS THROUGH THE C-FILES AFTER RUNS AND HAS DOUBT ON RESULT. IN THE C-FILES CT VALUE FOR CY5, HPV P3 = 27,58 / FINAL RESULT IS NEGATIVE. FOR CUSTOMER A CT VALUE OF 27,58 SHOULD NOT PROVIDE A NEGATIVE RESULT AS CONCLUSION THE SAMPLE HAS BEEN RETEST ON THE 2ND BD COR CT VALUE = 27,51 AND CONCLUSION IS NEGATIVE (THE SAMPLE IS POSITIVE FOR HPV45 AND HPV P2, ON BOTH SYSTEM).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17940973 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P160037. One submission often covers many models, so check the product and lot details in each record.

• Z-2162-2025 · Jun 23, 2025 · Open, Classified
  BD COR System Software. Model Number: 444829.