BD COR™ MX 443989Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00382904439897), received between Mar 25, 2025 and Mar 13, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (4 reports).

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

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Oct 31, 2024Open, 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-0588-2025 · Root cause: Software design · FDA record ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 13, 2026False Positive Result

  IT WAS REPORTED AFTER USING BD COR MX INSTRUMENT, THERE WAS ONE FALSE POSITIVE RESULT ON PATIENT SAMPLE. THE INSTRUMENT REPORTED POSITIVE FOR CHLAMYDIA, BUT THE SAMPLE WAS RETESTED THE NEXT DAY WITH A NEGATIVE RESULT. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24597677 ↗
• MalfunctionJun 10, 2025False Positive Result; False Positive Result

  IT WAS REPORTED DURING USE OF BD COR MX INSTRUMENT THERE WAS A FALSE POSITIVE RESULT FOR ALL MM2 TARGETS ON THE COR VAGINAL PANEL ASSAY. CONFIRMATORY TESTING WAS PERFORMED ON BD MAX INSTRUMENT AND INDICATED THAT ONLY ONE TARGET WAS POSITIVE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22181467 ↗
• MalfunctionApr 16, 2025False Positive Result; False Positive Result

  IT WAS REPORTED THAT DURING USE OF THE BD COR¿ MX, 8 SAMPLES WERE FALSE POSITIVE FOR BOTH CHLAMYDIA TRACHOMATIS AND NEISSERIA GONORRHOEAE. AFTER INSPECTING REAGENTS AND INSTRUMENT, A "BLOODY SLIME STRING" FROM A SAMPLE WAS FOUND DRAGGED OVER PROCESS AREA AND CONTAMINATED SAMPLES. CLEANING AND ENVIRONMENTAL TESTING WERE PERFORMED. SAMPLES WERE RERUN AND WERE NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21848839 ↗
• MalfunctionMar 25, 2025False Positive Result; False Positive Result

  IT WAS REPORTED AFTER USING BD COR MX INSTRUMENT, THERE WAS 1 FALSE POSITIVE RESULT FOR THE TRICHOMONAS VAGINALIS PANEL. CONFIRMATORY TESTING WAS PERFORMED ON THE BD MAX, WHERE THE RESULT WAS NEGATIVE. AFTER OBSERVING THE BD COR GRAPHS, THE CUSTOMER DISCOVERED THAT THE SAMPLE HAD JUST CROSSED THE THRESHOLD TO BE CALLED POSITIVE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21691589 ↗