BD ProbeTec™ (GC) Qx Amplified DNA Assay 441124Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00382904411244), received between Sep 7, 2022 and Sep 7, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “False Positive Result” (1 report).

1 other recall cover devices cleared under the same FDA submission (K081825, K090827, K090971, K091730); 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.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 7, 2022False Positive Result; False Positive Result

  IT WAS REPORTED THAT WHILE USING BD PROBETEC¿ NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY CONTAMINATION HAD BEEN NOTICED ON A PARTICULAR SECTION OF THE GC PLATES OVER A PERIOD OF TIME. RESULTS WERE CONSISTENT WITH CONTAMINATION OF THE ENVIRONMENT WITH GC INCLUDING THE LABORATORY AND ANALYZER. THE CUSTOMER HAD A RUN WHERE THERE WAS CONTAMINATION IN THE GC NEGATIVE CONTROL AND BLANKS ON PLATE 2 ONLY. THE LABORATORY AND INSTRUMENT WERE THOROUGHLY CLEANED AND THE RUN WAS REPEATED IN THE AFTERNOON WHICH HAD A VERY HIGH GC POSITIVITY RATE AND AGAIN NEGATIVE CONTROL CONTAMINATION, AND THIS AFFECTED BOTH PLATES. IN TOTAL THE CUSTOMER HAD 57 PATIENT POSITIVES OVER 1.5 RUNS. THESE RESULTS WERE NOT REPORTED OUT TO CLINICIANS. ONLY NEGATIVE RESULTS WERE RELEASED. PATIENTS WERE NOT TREATED AND THERE WAS NO PATIENT IMPACT. THERE WERE, HOWEVER, HUNDREDS OF PATIENT RESULTS DELAYED DUE TO THIS ISSUE AND HAVING DELAYS WITH STOCK DELIVERY. PATIENTS WITH A GC POSITIVE CONTROL WERE ALSO NOT REPORTED AND WERE INSTEAD SENT OUT AND REPEATED AT A REFERENCE LABORATORY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONTAMINATION HAS BEN NOTICED ON A PARTICULAR SECTION OF GC PLATES OVE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15375602 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K081825, K090827, K090971, K091730. One submission often covers many models, so check the product and lot details in each record.

• Z-1215-2013 · Feb 8, 2013 · Terminated
  BD ProbeTec Neisseria gonorrhoeae (GC) Qx Amplified DNA Assay Reagent Pack, REF 441124, contains 12 each Microwells labeled in part ***BD ProbeTec Neisseria gonorrhoeae (GC) Qx Amp