Creatinine plus ver2 5401470190Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04015630926862), received between Sep 12, 2018 and Aug 14, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Non Reproducible Results” (4 reports).

2 other recalls cover devices cleared under the same FDA submission (K024098); 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 14, 2025Non Reproducible Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE CREATININE PLUS VER.2 RESULTS FOR ONE SAMPLE FROM THE COBAS C 111 ANALYZER. THE INITIAL RESULT WAS 434.8 UMOL/L, AND THE REPEAT RESULT WAS 62.3 UMOL/L. THE QUESTIONABLE RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22802464 ↗
• MalfunctionOct 9, 2024Non Reproducible Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE CREATININE PLUS VER.2 RESULTS FROM THE COBAS C 111 ANALYZER. SAMPLE 1 INITIAL RESULT USING REAGENT LOT 77882101 WAS 1.57 MG/DL AND THE REPEAT RESULT WAS 0.77 MG/DL. ON (B)(6) 2024, SAMPLE 2 INITIAL RESULT USING REAGENT LOT 79431601 WAS 1.24 MG/DL AND THE REPEAT RESULTS WERE 0.64 MG/DL AND 0.62 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20409051 ↗
• MalfunctionDec 6, 2022Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR THREE PATIENT SAMPLES TESTED WITH CREP2 CREATININE PLUS VER.2 ON A COBAS C 111. THE FIRST PATIENT SAMPLE INITIALLY RESULTED IN A CREATININE VALUE OF 1.66 MG/DL AND REPEATED AS 1.30 MG/DL. THE 1.30 MG/DL VALUE WAS REPORTED OUTSIDE OF THE LABORATORY TO THE PATIENT. THE PATIENT WAS THEN TESTED IN ANOTHER LABORATORY AND THE CREATININE RESULT THERE WAS 0.69 MG/DL, SO THE PATIENT COMPLAINED ABOUT THE RESULT REPORTED AT THE CUSTOMER LABORATORY. THE ORIGINAL SAMPLE WAS REPEATED TWO TIMES ON (B)(6) 2022, RESULTING IN VALUES OF 0.68 MG/DL AND 2.71 MG/DL. THE SECOND PATIENT SAMPLE INITIALLY RESULTED IN A CREATININE VALUE OF 1.09 MG/DL AND THIS VALUE WAS REPORTED OUTSIDE OF THE LABORATORY TO THE PATIENT. DUE TO THE DISCREPANCY WITH THE FIRST SAMPLE, THE CUSTOMER DECIDED TO REPEAT THIS SAMPLE. THE SAMPLE WAS REPEATED TWICE ON (B)(6) 2022, RESULTING IN VALUES OF 0.83 MG/DL AND 3.28 MG/DL. THE THIRD PATIENT SAMPLE INITIALLY RESULTED IN A CREATININE VALUE OF 2.05 MG/DL AND REPEATED AS 1.20 MG/DL. THE 1.20 MG/DL VALUE WAS REPORTED OUTSIDE OF THE LABORATORY TO THE PATIENT. DUE TO THE DISCREPANCY WITH THE FIRST SAMPLE, THE CUSTOMER DECI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15927929 ↗
• MalfunctionSep 12, 2018Non Reproducible Results; Non Reproducible Results

  THE CUSTOMER RECEIVED QUESTIONABLE HIGH CREP2 CREATININE PLUS VER.2 RESULTS FOR SEVEN PATIENT SAMPLES FROM THE COBAS C 111 WITH ISE ANALYZER SERIAL NUMBER (B)(4). REFER TO THE ATTACHMENT TO THE MEDWATCH FOR ALL PATIENT DATA. THE ERRONEOUS RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. CALIBRATION AND QC RESULTS WERE ACCEPTABLE AND A GENERAL REAGENT ISSUE COULD BE EXCLUDED. THE PROBE WAS REPLACED AND THE WATER QUALITY WAS CHECKED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7867943 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K024098. One submission often covers many models, so check the product and lot details in each record.

• Z-1125-2019 · Dec 14, 2018 · Terminated
  cobas c 111 with ISE analyzers analyzer used in the following assays: a)Creatinine plus ver.2 Catalog Number: 05401470190; b)Triglycerides Catalog Number: 04657594190 - Product
• Z-0008-2009 · Jun 11, 2008 · Terminated
  Roche Diagnostics CREP2, Creatinine Plus Ver. 2, COBAS INTEGRA, cobas c systems, Roche Diagnostics, Indianapolis, IN.; 03263991190. An in-vitro diagnostic reagent system intended