ONLINE DAT Benzodiazepines Plus 08056919190Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613336170502), received between Mar 10, 2023 and Apr 29, 2024 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Non Reproducible Results” (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.

• MalfunctionApr 29, 2024False Positive Result; Incorrect, Inadequate or Imprecise Result or Readings; Non Reproducible Results; False Positive Result; Incorrect, Inadequate or Imprecise Result or Readings; Non Reproducible Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE BENZ BENZODIAZEPINES PLUS RESULTS FROM ABOUT THREE PATIENT SAMPLES TESTED ON THE COBAS C 303 ANALYTICAL UNIT - EMC. THE REPORTER STATED THERE WAS A POSSIBLE INTERFERENCE ISSUE WITH BENZODIAZEPINE PLUS TESTING. THE REPORTER WAS ABLE TO PROVIDE ONE EXAMPLE OF A QUESTIONABLE RESULT: THE INITIAL RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE PROVIDER ORDERED REFLEX TESTING AS THE RESULTS WERE FLAGGED AS PRESUMPTIVE POSITIVE. THE INITIAL RESULT FROM THE ANALYZER WAS "POSITIVE". THE REPEAT RESULT FROM ANOTHER LABORATORY USING THE LIQUID CHROMATOGRAPHY-MASS SPECTROMETRY (LC¿MS) LABORATORY METHOD WAS "NEGATIVE". THE REPEAT RESULT WAS DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19201365 ↗
• MalfunctionApr 24, 2024False Positive Result; Non Reproducible Results; False Positive Result; Non Reproducible Results

  THE INITIAL REPORTER QUESTIONED POSITIVE RESULTS FOR 2 PATIENT URINE SAMPLES TESTED FOR ONLINE DAT BENZODIAZEPINES PLUS (BENZ) ON A COBAS C 503 ANALYTICAL UNIT. PATIENT 1 RESULT FROM THE C503 ANALYZER WAS POSITIVE. ON (B)(6) 2024 PATIENT 2 RESULT FROM THE C503 ANALYZER WAS POSITIVE. THE SAMPLES WERE SENT TO AN EXTERNAL LABORATORY USING LIQUID CHROMATOGRAPHY-MASS SPECTROMETRY (LC/MS) AND THE RESULTS FOR BOTH SAMPLES WERE NEGATIVE. THE NEGATIVE RESULTS WERE BELIEVED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19175459 ↗
• MalfunctionJul 21, 2023Non Reproducible Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE BENZ BENZODIAZEPINES PLUS URINE RESULTS FOR 4 PATIENT SAMPLES ON A COBAS PRO C 503 ANALYTICAL UNIT. THE CUSTOMER STATED THAT THEY HAD BEEN PERFORMING A CORRELATION STUDY BETWEEN THE BENZ REAGENT AND THE NEW REAGENT VERSION. FOUR PATIENT SAMPLES GAVE A NEGATIVE BENZ RESULT AND A POSITIVE RESULT WITH THE NEW REAGENT VERSION. THE SAMPLES WERE SENT OUT FOR MASS SPECTROMETRY CONFIRMATION TESTING AND THE RESULTS WERE POSITIVE. THE CONFIRMATION RESULTS WERE DEEMED CORRECT. ONE OF THE PATIENTS' INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17374771 ↗
• MalfunctionJul 6, 2023False Negative Result; Incorrect, Inadequate or Imprecise Result or Readings; False Negative Result; Incorrect, Inadequate or Imprecise Result or Readings

  THE INITIAL REPORTER RECEIVED QUESTIONABLE BENZ BENZODIAZEPINES PLUS RESULTS FROM ONE URINE PATIENT SAMPLE TESTED ON THE COBAS PRO C 503 ANALYTICAL UNIT. THE INITIAL RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE DOCTOR QUESTIONED THE RESULT WHICH PROMPTED THE RERUN OF THE PATIENT SAMPLE. THE PATIENT SAMPLE WAS SENT FOR CONFIRMATORY TESTING TO ANOTHER LABORATORY THAT USES MASS SPECTROMETRY. ON (B)(6) 2023, THE INITIAL RESULT FROM THE ANALYZER WAS -131 MABS (NEGATIVE). ON (B)(6) 2023, THE PATIENT SAMPLE TESTED POSITIVE FOR TWO METABOLITES IN MASS SPECTROMETRY: OXAZEPAM (271 NG/ML) AND TEMAZEPAM (4093 NG/ML). ON (B)(6) 2023, THE FIRST REPEAT RESULT OF THE ALIQUOTED PATIENT SAMPLE WAS -124 MABS (NEGATIVE). THE SECOND REPEAT RESULT OF THE ALIQUOTED PATIENT SAMPLE WAS -122 MABS (NEGATIVE). THE THIRD REPEAT RESULT OF THE ALIQUOTED PATIENT SAMPLE WAS -119 MABS (NEGATIVE) THE POSITIVE RESULT WAS DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17269564 ↗
• MalfunctionMar 10, 2023False Negative Result; False Negative Result

  THERE WAS AN ALLEGATION OF QUESTIONABLE BENZ BENZODIAZEPINES PLUS RESULTS FOR 1 PATIENT ON A COBAS PRO C 503 ANALYTICAL UNIT COMPARED TO A TRIAGE METER AND GC/MS TESTING. ON (B)(6) 2023, THE PATIENT HAD 2 SEPARATE URINE SAMPLES THAT TESTED NEGATIVE FOR BENZ ON THE C503 ANALYZER. THE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE DOCTOR QUESTIONED THE RESULTS AS THE PATIENT IS CURRENTLY TAKING A BENZODIAZEPINE MEDICATION AND THE SAMPLES WERE REPEATED ON ANOTHER ANALYZER. THE SAMPLES WERE REPEATED ON A TRIAGE METER. THE FIRST SAMPLE HAD A RESULT OF 153 NG/DL, INTERPRETED AS POSITIVE, AND THE SECOND SAMPLE HAD A RESULT OF 439 NG/DL, INTERPRETED AS POSITIVE. ON (B)(6) 2023, THE PATIENT HAD A THIRD URINE SAMPLE COLLECTED THAT TESTED NEGATIVE FOR BENZ ON THE C503 ANALYZER. THE SAMPLE WAS REPEATED ON A TRIAGE METER AND THE RESULT WAS 44 NG/DL, INTERPRETED AS POSITIVE. ALL THREE SAMPLES WERE ALSO SENT OUT TO A REFERENCE LABORATORY AND ALL THREE SAMPLES GAVE POSITIVE RESULTS VIA GC/MS TESTING. THE POSITIVE RESULTS WERE DEEMED CORRECT. THE C503 ANALYZER SERIAL NUMBER IS (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16522855 ↗