ONLINE DAT Benzodiazepines II 04939417190Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04015630999347), received between Oct 18, 2024 and Aug 15, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 15, 2025False Positive Result; False Positive Result

  THE INITIAL REPORTER STATED THEY RECEIVED A QUESTIONABLE RESULT FOR ONE PATIENT URINE SAMPLE TESTED WITH ONLINE DAT BENZODIAZEPINES II ON A COBAS 8000 C 502 MODULE. THE SAMPLE INITIALLY RESULTED IN A POSITIVE BENZODIAZEPINES VALUE. THE VALUE WAS QUESTIONED. CONFIRMATION TESTING OF THE SAMPLE WAS PERFORMED USING A GAS CHROMATOGRAPHY MASS SPECTROMETRY (GC/MS) METHOD AT ANOTHER SITE AND THE BENZODIAZEPINES RESULT WAS NEGATIVE. THE NEGATIVE RESULT WAS DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22815977 ↗
• MalfunctionJan 27, 2025False Positive Result; Insufficient Device Problem Information; False Positive Result; Insufficient Device Problem Information

  WE RECEIVED AN ALLEGATION ABOUT QUESTIONABLE HIGH RESULTS FOR 1 PATIENT URINE SAMPLE TESTED WITH ONLINE DAT BENZODIAZEPINES II (BNZ2) ASSAY ON TWO DIFFERENT COBAS 6000 C (501) MODULES WHEN COMPARED TO A LIQUID CHROMATOGRAPHY¿MASS SPECTROMETRY (LC/MS) METHOD. INITIAL RESULT: POSITIVE (TESTED ON THE 1ST C501 MODULE. THE CUSTOMER STATED THAT THEY NOTICED QUESTIONABLE HIGH BNZ2 RESULTS SINCE ON (B)(6) 2024. THE SAMPLE WAS SENT OUT TO A PROVIDER TO BE RE-TESTED USING AN LC/MS METHOD AND THE RESULT WAS NEGATIVE. THE SAMPLE WAS THEN REPEATED ON ANOTHER C501 MODULE AT THE CUSTOMER'S SITE AND THE RESULT WAS POSITIVE. THE NEGATIVE RESULT WAS DEEMED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21242813 ↗
• MalfunctionOct 18, 2024False Positive Result; False Positive Result

  THE INITIAL REPORTER RECEIVED A QUESTIONABLE BNZ2 RESULT FROM ONE URINE FORENSIC PATIENT SAMPLE TESTED ON THE COBAS 6000 C 501 (UL) V. ON (B)(6) 2024: THE INITIAL RESULT FROM THE MODULE WAS 142 (POSITIVE). ON (B)(6) 2024: THE REPEAT RESULT FROM A XEVO ANALYZER THAT USES THE LIQUID CHROMATOGRAPHY - MASS SPECTROMETRY (LC-MS) LABORATORY METHOD WAS "NEGATIVE". THE REPEAT RESULT WAS DEEMED CORRECT. THE INITIAL RESULT WAS NOT REPORTED OUTSIDE THE LABORATORY AS THEY PERFORM REFLEX TESTING FOR FORENSIC PATIENT SAMPLES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20483061 ↗