ONLINE DAT Benzodiazepines II 08056927190Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613336121054), received between May 23, 2025 and Jul 14, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 14, 2025False Positive Result; False Positive Result

  THE INITIAL REPORTER STATED THEY RECEIVED FALSE POSITIVE RESULTS FOR THREE PATIENT SAMPLES TESTED WITH ONLINE DAT BENZODIAZEPINES II ON TWO COBAS C 503 ANALYTICAL UNIT ANALYZERS. THE FIRST PATIENT'S SAMPLE RESULTED IN A BENZODIAZEPINES VALUE OF 76.5 MABS (POSITIVE) WHEN TESTED ON THE FIRST C 503 ANALYZER AND IT RESULTED IN A VALUE OF 59.5 MABS (POSITIVE) WHEN TESTED ON THE SECOND C 503 ANALYZER. THE SAMPLE WAS SENT TO ANOTHER LABORATORY FOR GC/MS CONFIRMATION TESTING AND THE RESULT WAS NEGATIVE (SEE ATTACHMENT FOR FULL RESULTS). THE SECOND PATIENT'S SAMPLE RESULTED IN A BENZODIAZEPINES VALUE OF 12.5 MABS (POSITIVE) WHEN TESTED ON THE FIRST C 503 ANALYZER ON (B)(6) 2025 AND IT RESULTED IN A POSITIVE WHEN TESTED ON THE SECOND C 503 ANALYZER ON (B)(6) 2025. THE SAMPLE WAS SENT TO ANOTHER LABORATORY FOR GC/MS CONFIRMATION TESTING AND THE RESULT WAS NEGATIVE (SEE ATTACHMENT FOR FULL RESULTS). THE THIRD PATIENT'S SAMPLE RESULTED IN A BENZODIAZEPINES VALUE OF 10.8 MABS (POSITIVE) WHEN TESTED ON THE FIRST C 503 ANALYZER ON (B)(6) 2025 AND IT RESULTED IN A VALUE OF 20.9 MABS (POSITIVE) WHEN TESTED ON THE SECOND C 503 ANALYZER ON (B)(6) 2025. THE SAMPLE WAS SENT TO ANOTHER LABORATORY FOR GC/

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22493339 ↗
• MalfunctionMay 23, 2025False Positive Result; Incorrect, Inadequate or Imprecise Result or Readings; False Positive Result; Incorrect, Inadequate or Imprecise Result or Readings

  THERE WAS AN ALLEGATION OF A QUESTIONABLE FALSE POSITIVE ONLINE DAT BENZODIAZEPINES II RESULT FROM THE COBAS PRO SSU. THE PATIENT HAD AN INITIAL POSITIVE RESULT. THE REPEAT RESULT BY LC/MS WAS NEGATIVE FOR BENZODIAZEPINES INCLUDING SO-7-AMINOCLONAZEPAM, SO-7-AMINOFLUNITRAZEPAM, SO-ALPHA HYDROXYALPRAZOLAM, SO-LORAZEPAM, SO-NORDIAZEPAM, SO-OXAZEPAM, AND SO-TEMAZEPAM. THIS RESULT THAT WAS DEEMED TO BE CORRECT. THE RESULTS WERE NOT RELEASED OUTSIDE OF THE LABORATORY. THE SAMPLE WAS REPEATED AS THE CUSTOMER HAS HAD OTHER INITIALLY POSITIVE DRUG SCREENINGS THAT WERE REPEATED AND FOUND TO BE NEGATIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22080634 ↗