Creatinine plus ver.2 08057524190Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 07613336121160), received between Dec 14, 2022 and Sep 29, 2026 — classified as 20 malfunctions.

The most frequently reported specific device problem is “Non Reproducible Results” (8 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. 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Incorrect Measurement

  There was an allegation of questionable Creatinine plus ver.2 results for several patient samples on a cobas c (b)(4) analytical unit.An interference with monoclonal gammopathy IgM was suspected.Three patient examples were provided.Patient 1:The initial results were 337 µmol/L (serum) and 314 µmol/L (heparin plasma).The sample was tested in another laboratory on another module (cobas c 503), and the result was approximately 60 µmol/L The sample was repeated on the same module as the initial results, and the result was 300 µmol/L.Patient 2:The initial results were 338 µmol/L and 359 µmol/L (serum and heparin plasma). The results were obtained on 2 different cobas c 703 modules.A new sample was tested at a different laboratory on another module (cobas c 501), and the result was 87 µmol/L.A third sample was tested on one of the same modules as the initial sample, and the result was approximately 330 µmol/L.Patient 3: The initial result was 215 µmol/L.It was alleged that a new sample was tested at another laboratory, but the result was not provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50931151 ↗
• MalfunctionSep 22, 2026Non Reproducible Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50857213 ↗
• MalfunctionSep 16, 2026Non Reproducible Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50791937 ↗
• MalfunctionAug 19, 2026Non Reproducible Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50320783 ↗
• MalfunctionMar 26, 2026High Test Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED WITH CREATININE PLUS VER.2 ASSAY ON A COBAS C 503 ANALYTICAL UNIT, NOT MATCHING THE EXPECTATIONS. SAMPLE 1 WAS DRAWN AND TESTED, RESULTING IN A CREATININE VALUE OF 1496 MOL/L. THE HIGH CREATININE VALUE PROMPTED A NEW SAMPLE (SAMPLE 2) TO BE DRAWN AND TESTED, RESULTING IN A CREATININE VALUE OF 29.8 MOL/L. THE RESULT OF 29.8 MOL/L WAS CONSIDERED NORMAL. AN EMLAPATCH WAS USED ON THE PATIENT; LIKELY, THE SKIN WAS NOT CLEANED AFTER REMOVAL AND BEFORE SAMPLING. THE CUSTOMER SUSPECTED AN INTERFERENCE DURING THE SAMPLE DRAWING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24701380 ↗
• MalfunctionMar 18, 2026Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE CREATININE PLUS VER.2 RESULTS FOR 1 PATIENT ON A COBAS C 503 ANALYTICAL UNIT. THE INITIAL RESULT WAS 555 MOL/L, AND THE REPEATED RESULT WAS 525 MOL/L. THE PHYSICIAN QUESTIONED THE RESULTS, AND THE SAMPLE WAS REPEATED. THE REPEATED RESULTS WERE 641 MOL/L, 65.3 MOL/L, 366 MOL/L, 368 MOL/L, 367 MOL/L, 367 MOL/L, AND 368 MOL/L. A SECOND SAMPLE (COLLECTED AT THE SAME TIME AS THE FIRST SAMPLE) FROM THE SAME PATIENT WAS TESTED, AND THE RESULTS WERE 65.0 MOL/L, 65.3 MOL/L, 65.3 MOL/L, 66.5 MOL/L, 66.2 MOL/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24627982 ↗
• MalfunctionMar 2, 2026Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results; Output Problem

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED WITH CREATININE PLUS VER.2 ASSAY ON A COBAS PURE C 303 ANALYTICAL UNIT. INITIAL RESULT: 16.8 UMOL/L. THE PHYSICIAN QUESTIONED THE INITIAL RESULT AS IT DID NOT MATCH THE PATIENT'S CLINICAL PICTURE, AND THE SAMPLE WAS THEN REPEATED. REPEAT RESULT: 85.8 UMOL/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24481760 ↗
• MalfunctionNov 26, 2025High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF A QUESTIONABLE CREATININE PLUS VER.2 RESULT FROM THE COBAS C 503 ANALYTICAL UNIT FOR ONE PATIENT. THE INITIAL RESULT WAS 251 MOL/L, AND THE REPEAT RESULT WAS 63.1 MOL/L. THE INITIAL RESULT WAS SIGNIFICANTLY HIGHER THAN EXPECTED AND WAS REPEATED. THE QUESTIONABLE RESULT WAS NOT RELEASED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23657391 ↗
• MalfunctionNov 4, 2025High Test Results; High Test Results

  THE INITIAL REPORTER COMPLAINED OF A DISCREPANT HIGH RESULT FOR 1 PATIENT SAMPLE TESTED FOR CREATININE PLUS VER.2 (CREP2) ON A COBAS C 503 ANALYTICAL UNIT. THE INITIAL RESULT WAS 112 UMOL/L. THE REPEAT RESULT WAS 10.4 UMOL/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23468602 ↗
• MalfunctionOct 27, 2025Non Reproducible Results; Non Reproducible Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED WITH CREATININE PLUS VER.2 ASSAY ON A COBAS C 503 ANALYTICAL UNIT. INITIAL RESULT: 0.54 MG/DL. REPEAT RESULT: 1.66 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23393117 ↗
• MalfunctionMar 11, 2025High Test Results; High Test Results

  THE INITIAL REPORTER COMPLAINED OF A DISCREPANT HIGH RESULT FOR 1 PEDIATRIC PATIENT SAMPLE TESTED FOR CREATININE PLUS VER.2 (CREP2) COBAS C 503 ANALYTICAL UNIT. THE INITIAL RESULT WAS 0.86 MG/DL. THE SAMPLE WAS REPEATED TWICE WITH RESULTS OF 0.17 MG/DL AND 0.19 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21571902 ↗
• MalfunctionSep 25, 2024Incorrect Measurement; Incorrect Measurement

  THERE WAS AN ALLEGATION OF QUESTIONABLE COBAS CREATININE PLUS VER.2 ASSAY RESULTS FROM THE COBAS C 503 ANALYTICAL UNIT. THE INITIAL RESULT WAS 22.1 MG/DL. ON 01-SEP-2024, THE REPEAT RESULT WAS 1.29 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20304847 ↗
• MalfunctionSep 13, 2024Low Test Results; Low Test Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE CREATININE (CREAP2) RESULTS FROM ONE PATIENT SAMPLE TESTED ON THE COBAS PURE C 303 ANALYTICAL UNIT. THE INITIAL RESULT WAS 29.40 UMOL/L. THE REPEAT RESULT WAS 28.80 UMOL/L. THE REPORTER STATED THAT THE RESULTS WERE LOWER THAN THE NORMAL VALUES AND COULD NOT EXPLAINED BY THE PATIENT'S MEDICAL CONDITION. THE PHYSICIAN SUSPECTS AN INTERFERENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20212012 ↗
• MalfunctionJun 6, 2024Incorrect Measurement; Incorrect Measurement

  THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE RESULTS FOR AN UNSPECIFIED NUMBER OF SAMPLES FROM ONE PATIENT TESTED WITH THE COBAS CREATININE PLUS VER.2 ASSAY ON A COBAS C 503 ANALYTICAL UNIT AND AN UNKNOWN ROCHE ANALYZER AT ANOTHER SITE. CREATININE RESULTS MEASURED ON THE CUSTOMER'S C 503 ANALYZER HAVE RESULTS CLOSE TO 170 UMOL/L. WHEN SAMPLES FROM THE PATIENT ARE TESTED IN ANOTHER LABORATORY ON A COMPETITOR SYSTEM (COMPETITOR 1), THE CREATININE RESULTS ARE CLOSE TO 60 - 70 UMOL/L. THE CUSTOMER PROVIDED AN EXAMPLE OF RESULTS FROM ONE OF THE PATIENT'S SAMPLES. WHEN THIS SAMPLE WAS TESTED ON THE CUSTOMER'S C 503 ANALYZER, THE CREATININE RESULT WAS > 175 UMOL/L. WHEN TESTED ON A COMPETITOR SYSTEM (COMPETITOR 2) IN THE CUSTOMER'S LABORATORY, THE CREATININE RESULT IS > 71 UMOL/L. WHEN TESTED ON AN UKNOWN ROCHE SYSTEM IN ANOTHER LABORATORY, THE CREATININE RESULT IS > 174 UMOL/L. A DIFFERENT SAMPLE COLLECTED FROM THE PATIENT WAS TESTED IN ANOTHER LABORATORY USING A COMPETITOR SYSTEM (COMPETITOR 1) AND THE CREATININE RESULT WAS 63 UMOL/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19477278 ↗
• MalfunctionOct 18, 2023Low Test Results; Low Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH CREP2 (CREATININE) ON A COBAS PRO C 503 ANALYTICAL UNIT. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE INITIALLY RESULTED IN A CREATININE VALUE OF 0.156 MG/DL. AS THE RESULT WAS NOT IN LINE WITH THE PATIENT'S CLINICAL HISTORY, THE SAMPLE WAS REPEATED. THE REPEAT CREATININE VALUE WAS 1.42 MG/DL. THE REPEAT VALUE WAS CONSIDERED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17962080 ↗
• MalfunctionApr 28, 2023High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR TWO SAMPLES COLLECTED ON THE SAME DAY FROM ONE PATIENT AND TESTED WITH THE CREP2 (CREATININE PLUS VER.2) ASSAY ON A COBAS PRO C 503 ANALYTICAL UNIT, SERIAL NUMBER (B)(4). FIRST PATIENT SAMPLE, TESTED OUT OF A PRIMARY TUBE: THE SAMPLE INITIALLY RESULTED IN A CREP2 VALUE OF 30.7 MG/L. ON (B)(6)2023, THE SAMPLE WAS REPEATED TWO TIMES, RESULTING IN CREP2 VALUES OF 19.2 MG/L AND 19.4 MG/L. SECOND PATIENT SAMPLE, TESTED OUT OF A SECONDARY TUBE: THE SAMPLE INITIALLY RESULTED IN A CREP2 VALUE OF 9.05 MG/L AND REPEATED AS 8.8 MG/L. THE QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16835214 ↗
• MalfunctionApr 19, 2023Low Test Results; Low Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR MULTIPLE PATIENT SAMPLES TESTED WITH ONE SPECIFIC CREP2 (CREATININE PLUS VER. 2) REAGENT CASSETTE ON A COBAS PRO C 503 ANALYTICAL UNIT, SERIAL NUMBER (B)(4). THE REPORTER MENTIONED QUALITY CONTROL ISSUES FOR THE REAGENT CASSETTE AND SUBSEQUENTLY, APPROXIMATELY 120 PATIENT PLASMA AND URINE SAMPLES WERE MEASURED. THE REAGENT CASSETTE WAS THEN REPLACED AND THE PATIENT SAMPLES WERE REPEATED, SHOWING ABOUT 30 % HIGHER RESULTS. OF THE DATA PROVIDED THE FOLLOWING DISCREPANT RESULTS FOR 5 PATIENT PLASMA SAMPLES ARE REPRESENTATIVE EXAMPLES. PATIENT SAMPLE 1 INITIALLY RESULTED IN A CREP2 VALUE OF 301 UMOL/L AND REPEATED AS 448 UMOL/L WITH THE SECOND REAGENT CASSETTE. PATIENT SAMPLE 2 INITIALLY RESULTED IN A CREP2 VALUE OF 163 UMOL/L AND REPEATED AS 240 UMOL/L WITH THE SECOND REAGENT CASSETTE. PATIENT SAMPLE 3 INITIALLY RESULTED IN A CREP2 VALUE OF 65 UMOL/L AND REPEATED AS 89.9 UMOL/L WITH THE SECOND REAGENT CASSETTE. PATIENT SAMPLE 4 INITIALLY RESULTED IN A CREP2 VALUE OF 113 UMOL/L AND REPEATED AS 172 UMOL/L WITH THE SECOND REAGENT CASSETTE. PATIENT SAMPLE 5 INITIALLY RESULTED IN A CREP2 VALUE OF 54 UMOL/L AND REPEATED AS 83.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16771582 ↗
• MalfunctionMar 21, 2023Incorrect Measurement; Incorrect Measurement

  WE RECEIVED AN ALLEGATION OF DISCREPANT RESULTS FOR 2 SAMPLES FROM THE SAME PATIENT TESTED CREATININE (CREP2) ASSAY ON A COBAS PRO C 503 ANALYTICAL UNIT SERIAL NUMBER (B)(4). ON (B)(6) 2023 THE CUSOMER RAN THE PATIENT'S SAMPLES AND RECEIVED THE FOLLOWING CREP2 RESULTS: SAMPLE 1: THE INITIAL RESULT WAS 136 MOL/L. THE FIRST REPEATED RESULT WAS 65.8 MOL/L . THE SECOND REPEATED RESULT WAS 66 MOL/L. THE THIRD REPEATED RESULT, ON A DIFFERENT INSTRUMENT, THE RESULT WAS 66 MOL/L. SAMPLE 2: THE INITIAL RESULT WAS 203 MOL/L. THE FIRST REPEATED RESULT WAS 66 MOL/L. THE SECOND REPEATED RESULT WAS 66 MOL/L. THE THIRD REPEATED RESULT, ON A DIFFERENT INSTRUMENT, THE RESULT WAS 66 MOL/L. THE PATIENT WAS ADMITTED TO THE EMERGENCY ROOM DUE TO A CHEST PAIN AND SHE WAS TREATED WITH AN NACL INFUSION. AND THE ABOVE TESTS WERE PERFORMED. CALIBRATION AND QC WERE WITHIN SPECIFICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16584855 ↗
• MalfunctionFeb 14, 2023Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH THE CREP2 (CREATININE PLUS VER.2) ASSAY ON A COBAS C 503 ANALYTICAL UNIT. THE SAMPLE INITIALLY RESULTED IN A CREP2 VALUE OF 86.2 MOL/L AND REPEATED AS 60.1 MOL/L. THE INITIAL QUESTIONABLE RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE CREP2 REAGENT LOT WAS 67171801 WITH AN EXPIRATION DATE OF (B)(6)2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16374958 ↗
• MalfunctionDec 14, 2022Non Reproducible Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF A QUESTIONABLE CREATININE PLUS VER.2 RESULT FROM THE COBAS PRO C 503 ANALYTICAL UNIT. THE INITIAL RESULT WAS 164 MOL/L AND THE REPEAT RESULTS WERE 49 MOL/L AND 52 MOL/L. THE QUESTIONABLE RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THE REAGENT LOT NUMBER WAS 64318001 WITH AN EXPIRATION DATE OF 28-FEB-2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15978689 ↗

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 - Pro
• 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