Benzodiazepines Plus 4490789190Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04015630997718), received between Jul 27, 2018 and Jan 4, 2024 — classified as 5 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 16, 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.

• MalfunctionJan 4, 2024False Negative Result; Non Reproducible Results; False Negative Result; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE BENZODIAZEPINES PLUS RESULTS FOR 2 PATIENT SAMPLES ON A COBAS 6000 C (501) MODULE COMPARED TO A COBAS C303 MODULE. PATIENT SAMPLE 1: THE INITIAL RESULT WAS 200 MABS, PERFORMED ON A COBAS C303 MODULE. THE SAMPLE WAS REPEATED ON THE SAME MODULE AND THE RESULT WAS 201 MABS. THE POSITIVE RESULTS WERE QUESTIONED DUE TO A TEST FLAG IN THE INSTRUMENT MANAGER. THE SAMPLE WAS REPEATED ON THE C501 MODULE AND THE RESULT WAS 9 MABS. THE NEGATIVE RESULT FROM THE C501 WAS REPORTED TO THE PROVIDER BUT THE CUSTOMER IS UNSURE WHICH RESULT IS CORRECT. CONFIRMATION RESULTS (GCMS) FOR PATIENT SAMPLE 1: THE NORDIAZEPAM RESULT WAS 16 NG/ML WITH A CUTOFF OF 10 NG/ML. THE OXAZEPAM RESULT WAS 61 NG/ML WITH A CUTOFF OF 10 NG/ML. THE TEMAZEPAM WAS 41 NG/ML WITH A CUTOFF OF 10 NG/ML. PATIENT SAMPLE 2: THE INITIAL RESULT WAS 358 MABS, PERFORMED ON A COBAS C303 MODULE. THE SAMPLE WAS REPEATED ON THE SAME MODULE AND THE RESULT WAS 362 MABS. THE POSITIVE RESULTS WERE QUESTIONED DUE TO A TEST FLAG IN THE INSTRUMENT MANAGER. THE SAMPLE WAS REPEATED ON THE C501 MODULE AND THE RESULT WAS 27 MABS. INITIALLY, THE POSITIVE RESULTS WERE REPORTED OUTSIDE OF THE LABORATOR, BUT A CORR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18443270 ↗
• MalfunctionJul 17, 2023False Positive Result; False Positive Result

  WE RECEIVED AN ALLEGATION OF DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED FOR BENZODIAZEPINES PLUS (BENZ) ON A COBAS 6000 C (501) MODULE. THE RESULT FROM THE C 501 MODULE WAS "POSITIVE." THE SPECIFIC RESULT WAS NOT PROVIDED. THE POSITIVE RESULT WAS REPORTED OUTSIDE OF THE LABORATORY WHERE IT WAS QUESTIONED. THE SAMPLE WAS NOT REPEATED ON THE C501 MODULE. THE SAMPLE WAS SENT FOR TESTING BY LIQUID CHROMATOGRAPHY-MASS SPECTROMETRY (LC/MS) AND THE RESULT WAS "NEGATIVE." THE NEGATIVE RESULT WAS BELIEVED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17339496 ↗
• MalfunctionMar 6, 2023False Positive Result; Non Reproducible Results; False Positive Result; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED A QUESTIONABLE RESULT FOR ONE PATIENT SAMPLE TESTED WITH BENZODIAZEPINES PLUS ON A COBAS 6000 C (501) MODULE (SERIAL NUMBER (B)(4)). THE SAMPLE INITIALLY RESULTED IN A BENZODIAZEPINES VALUE OF -287 MABS (NEGATIVE) AND THIS VALUE WAS REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE WAS AUTOMATICALLY REPEATED BY THE ANALYZER, RESULTING IN A VALUE OF 87 MABS (POSITIVE). THE SAMPLE WAS REPEATED AN ADDITIONAL TIME, RESULTING IN A VALUE OF 88 MABS (POSITIVE). THE POSITIVE VALUE OF 87 MABS WAS DEEMED CORRECT BY THE CUSTOMER AND A CORRECTED REPORT WAS ISSUED. THE SAMPLE WAS REPEATED USING THE GC/MS BENZODIAZEPINES METHOD, AND THE RESULT WAS NEGATIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16490800 ↗
• MalfunctionAug 17, 2018Low Test Results; Low Test Results

  THE CUSTOMER COMPLAINED OF FALSE NEGATIVE BENZ BENZODIAZEPINES PLUS RESULTS FOR 4 PATIENT URINE SAMPLES ON A COBAS 6000 C (501) MODULE SERIAL NUMBER (B)(4). OF THE DATA PROVIDED, THERE WAS A DISCREPANT BENZ RESULT FOR 1 PATIENT URINE SAMPLE. THE BENZODIAZEPINES RESULT WAS NEGATIVE ON THE C 501 MODULE. THE PHYSICIAN QUESTIONED THE RESULT AND REQUESTED CONFIRMATION TESTING AS THE PATIENT WAS TAKING CLONAZEPAM. THE AMINOCLONAZEPAM RESULT WAS 156 NG/ML WITH THE MEDMATCH MASS SPECTROPHOTOMETRY USING THE SAME SAMPLE. ACCORDING TO PRODUCT LABELING, A 7-AMINOCLONAZEPAM RESULT OF 144 NG/ML OR GREATER SHOULD YIELD A POSITIVE RESULT. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE PRODUCT LABELING STATES "MANY BENZODIAZEPINES APPEAR IN THE URINE LARGELY AS THE GLUCURONIDATED CONJUGATE. GLUCURONIDATED METABOLITES MAY HAVE MORE OR LESS CROSS-REACTIVITY THAN THE PARENT COMPOUND." THE CUSTOMER DECLINED A SERVICE VISIT. THE INVESTIGATION WAS UNABLE TO FIND A DEFINITIVE ROOT CAUSE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7792458 ↗
• MalfunctionJul 27, 2018Low Test Results; Low Test Results

  THE CUSTOMER IS HAVING ISSUES DETECTING CLONAZEPAM IN A PATIENT SAMPLE USING THE BENZODIAZEPINES PLUS (BENZ) ASSAY ON A COBAS 6000 C (501) MODULE. THE CUSTOMER COMPLAINED OF A FALSE NEGATIVE RESULT FOR 1 PATIENT SAMPLE TESTED FOR BENZ. PREVIOUS PATIENT SAMPLES HAVE HAD SIMILAR ISSUES. USING THE 300 NG/ML CUTOFF, THE CUSTOMER GOT AN INITIAL BENZ RESULT OF [-] 34, NEGATIVE. THE CUSTOMER REPORTED OUT THE NEGATIVE RESULT TO THE PHYSICIAN, BUT THEY INFORMED THE PHYSICIAN THEY WERE DOING ADDITIONAL CONFIRMATION TESTING. THE SAMPLE WAS SENT TO AN OUTSIDE LABORATORY AND THE SAMPLE WAS CONFIRMED POSITIVE FOR CLONAZEPAM WITH A RESULT OF 1124 NG/ML. THE PATIENT SAMPLE WAS TESTED ON THE COBAS C501 ON (B)(6) 2018 USING THE 100 NG/ML CUTOFF AND THE RESULTS WERE POSITIVE. THE SPECIFIC RESULTS WERE 27 AND 26 BOTH RESULTS WITH A DATA FLAG. THE CUSTOMER DEEMED THESE POSITIVE RESULTS AS CORRECT. THERE WAS NO ADVERSE EVENT. THE COBAS C501 SERIAL (B)(4). THE INVESTIGATION IS CURRENTLY ONGOING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7727794 ↗