Creatinine Jaffe Gen.2 08057532190Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 07613336121177), received between Nov 11, 2022 and Aug 25, 2026 — classified as 17 malfunctions.

The most frequently reported specific device problem is “Non Reproducible Results” (13 reports).

7 other recalls cover devices cleared under the same FDA submission (K951595); 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 25, 2026High Test Results; Non Reproducible Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50438134 ↗
• MalfunctionFeb 13, 2026High Test Results; Non Reproducible Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED WITH CREATININE JAFFE GEN.2 ASSAY ON A COBAS C 503 ANALYTICAL UNIT. INITIAL RESULT: 0.96 MG/DL. THE PHYSICIAN QUESTIONED THE INITIAL RESULT, PROMPTING THE REPEAT OF THE SAMPLE. REPEAT RESULT: 0.34 MG/DL. A NEW SAMPLE WAS DRAWN AND TESTED, RESULTING IN A VALUE MATCHING THE REPEAT RESULT. THE REPEAT RESULT WAS DEEMED TO BE CORRECT AS IT MATCHED THE PATIENT'S PREVIOUS RESULTS AND THE RESULT FROM THE NEW SAMPLE. REPORTEDLY, AN AMENDED REPORT WITH THE CORRECT RESULT WAS ISSUED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24333688 ↗
• MalfunctionJan 30, 2026Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE CREATININE JAFFE GEN.2 RESULTS FROM THE COBAS C 503 ANALYTICAL UNIT. THE INITIAL RESULT WAS 1.9 (1.88) MG/DL. A DOCTOR CONTACTED THE LAB BECAUSE THE RESULT DID NOT MATCH THE PATIENT'S MEDICAL HISTORY AND ASKED FOR THE TEST TO BE REPEATED. WHEN THE TEST WAS REPEATED ON COBAS PRO LINE, THE RESULT WAS 0.9 (0.883) MG/DL. THIS RESULT WAS BELIEVED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24223461 ↗
• MalfunctionJul 3, 2025Non Reproducible Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE CREATININE JAFFE GEN.2 RESULTS FROM THE COBAS C 503 ANALYTICAL UNIT. THE INITIAL RESULT WAS 2.81 MG/DL, WHICH DID NOT ALIGN WITH THE PATIENT'S CLINICAL PROFILE. THE DOCTOR CONTACTED THE LABORATORY AND ASKED TO REPEAT THE TEST. ON (B)(6) 2025, THE SAME SAMPLE WAS REPEATED, AND THE RESULT WAS 1.75 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22393784 ↗
• MalfunctionMay 27, 2025Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED A QUESTIONABLE RESULT FOR ONE PATIENT SAMPLE TESTED WITH CREATININE JAFFE GEN.2 ON A COBAS C 503 ANALYTICAL UNIT. THE SAMPLE INITIALLY RESULTED IN A CREATININE RESULT OF 0.662 MG/DL WHEN TESTED ON THE C 503 ANALYZER. THE SAMPLE WAS REPEATED ON A BECKMAN ANALYZER, RESULTING IN A CREATININE VALUE OF 2.31 MG/DL. THE CUSTOMER ACCEPTED THIS RESULT SINCE IT WAS MORE COMPATIBLE WITH THE PATIENT'S HISTORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22087057 ↗
• MalfunctionJan 9, 2025Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 2 PATIENT SAMPLES TESTED FOR CREATININE JAFFE GEN.2 (CREAJ2) ON A COBAS C 503 ANALYTICAL UNIT. FOR BOTH PATIENTS, THE INITIAL RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY AND A 2ND SAMPLE WAS REQUESTED. THE RESULTS FOR THE 2ND SAMPLE WERE NOT PROVIDED. THE ORIGINAL TUBE WAS THEN REPEATED. PATIENT 1 INITIAL RESULT WAS 0.17 MG/DL WITH A DATA FLAG. THE REPEAT RESULT WAS "COMPARABLE TO THE PREVIOUS HISTORY" (3 MG/DL); THE SPECIFIC RESULT WAS NOT PROVIDED. PATIENT 2 INITIAL RESULT WAS 0.14 MG/DL WITH A DATA FLAG. THE REPEAT RESULT WAS "COMPARABLE TO THE PREVIOUS HISTORY" (8 MG/DL); THE SPECIFIC RESULT WAS NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21114937 ↗
• MalfunctionDec 3, 2024Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR THREE SAMPLES COLLECTED FROM THE SAME PATIENT AND TESTED WITH CREATININE JAFFE GEN.2 ON A COBAS PURE C 303 ANALYTICAL UNIT AND COBAS INTEGRA 400 PLUS ANALYZERS. THE SECOND AND THIRD SAMPLES WERE ALSO TESTED ON A C303 ANALYZER, A COBAS C 311 ANALYZER, AND TWO ADDITIONAL INTEGRA 400 PLUS ANALYZERS AT OTHER SITES. THE FIRST SAMPLE RESULTED IN A CREATININE VALUE OF 102 UMOL/L WHEN TESTED ON THE CUSTOMER'S C 303 ANALYZER. THE SAMPLE WAS REPEATED ON THE CUSTOMER'S INTEGRA 400 PLUS ANALYZER, RESULTING IN A VALUE OF 39 UMOL/L. THE SECOND SAMPLE RESULTED IN THE FOLLOWING CREATININE VALUES: ON THE CUSTOMER'S C 303 ANALYZER = 109 UMOL/L AND 108 UMOL/L ON THE CUSTOMER'S INTEGRA 400 PLUS ANALYZER = 42 UMOL/L AND 45 UMOL/L ON A SECOND C303 SYSTEM AT A SECOND SITE = 105 UMOL/L ON A C311 ANALYZER AT A SECOND SITE = 84 UMOL/L AND 90 UMOL/L WITH A DATA FLAG ON A SECOND INTEGRA 400 PLUS ANALYZER AT A THIRD SITE = 51 UMOL/L ON A THIRD INTEGRA 400 PLUS ANALYZER AT A THIRD SITE = 46 UMOL/L THE THIRD SAMPLE RESULTED IN THE FOLLOWING CREATININE VALUES: ON THE CUSTOMER'S C 303 ANALYZER = 120 UMOL/L ON THE CUSTOMER'S INTEGRA 400 PLUS ANALYZER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20831414 ↗
• MalfunctionNov 19, 2024Low Test Results; Low Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE CREATININE JAFFE GEN.2 RESULTS FOR AN UNKNOWN NUMBER OF PATIENT SAMPLES ON A COBAS C 303 ANALYTICAL UNIT. ONE EXAMPLE WAS PROVIDED: THE INITIAL RESULT WAS 0.870 MG/DL. THE REPEATED RESULT WAS 1.20 MG/DL. THIS RESULT WAS REPORTED OUTSIDE THE LABORATORY. THE SAMPLE WAS REPEATED BECAUSE THE QUESTIONABLE RESULT DID NOT MATCH THE PATIENT'S UREA RESULT AND CLINICAL HISTORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20726857 ↗
• MalfunctionOct 10, 2024Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH CREATININE JAFFE GEN.2 ON A COBAS C 503 ANALYTICAL UNIT. THE SAMPLE INITIALLY RESULTED IN A CREATININE VALUE OF 0.93 MG/DL. THE VALUE DID NOT AGREE WITH THE HISTORICAL DATA OF THE PATIENT. THE PATIENT SAMPLE WAS REPEATED, RESULTING IN A CREATININE VALUE OF 0.13 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20417651 ↗
• MalfunctionMay 16, 2024Incorrect Measurement; Non Reproducible Results; Incorrect Measurement; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE CREATININE JAFFE GEN.2 RESULTS FOR ONE LIPEMIC PATIENT SAMPLE FROM THE COBAS C 503 ANALYTICAL UNIT. THE INITIAL RESULT WAS 0.46 MG/DL. A NEW SAMPLE WAS DRAWN ON (B)(6) 2024 AND THE RESULT WAS 0.639 WITH DATA FLAG. AFTER HIGH-SPEED CENTRIFUGE, THE REPEAT RESULT WAS 1.02 MG/DL AND WAS REPORTED OUTSIDE OF THE LABORATORY. ON (B)(6) 2024, THE REPEAT RESULT USING THE ORIGINAL SAMPLE WAS 0.98 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19330676 ↗
• MalfunctionJan 2, 2024Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Non Reproducible Results; Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Non Reproducible Results

  THE INITIAL REPORTER RECEIVED A QUESTIONABLE CREJ2 CREATININE JAFFÉ GEN.2 RESULT FROM ONE PATIENT SAMPLE TESTED ON THE COBAS PRO C 503 ANALYTICAL UNIT. THE INITIAL RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE FLOOR NURSE DEEMED THE RESULT CRITICAL PROMPTING THE RERUN OF THE PATIENT SAMPLE. THE PATIENT SAMPLE WAS RERUN ON THE ANALYZER AND TWO OTHER MODULES: MODULE A AND MODULE B. ON (B)(6) 2023. THE INITIAL RESULT FROM THE ANALYZER WAS 4.49 MG/DL. THE FIRST REPEAT RESULT FROM MODULE A WAS 0.724 MG/DL. THIS REPEAT RESULT WAS DEEMED CORRECT. THE SECOND REPEAT RESULT FROM MODULE B WAS 0.766 MG/DL. ON (B)(5). THE THIRD REPEAT RESULT FROM THE ANALYZER WAS 0.745 MG/DL. THE FOURTH REPEAT RESULT FROM THE ANALYZER WAS 0.754 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18424437 ↗
• MalfunctionNov 10, 2023Non Reproducible Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE CREJ2 CREATININE JAFFÉ GEN.2 RESULTS FOR 1 PATIENT ON A COBAS PRO C 503 ANALYTICAL UNIT. THE CUSTOMER QUESTIONED THE PATIENT'S RESULTS AS THEY NOTICED FLUCTUATION ACROSS MULTIPLE SAMPLES AND SUSPECT A POSSIBLE DRUG INTERFERENCE. ON (B)(6)2023, THE PATIENT HAD A CREJ2 RESULT OF 61 UMOL/L. ON (B)(6)2023, THE PATIENT HAD A CREJ2 RESULT OF 170 UMOL/L AND A SECOND RESULT OF 140 UMOL/L. ON (B)(6)2023, THE PATIENT HAD A CREJ2 RESULT OF 296 UMOL/L AND A SECOND RESULT OF 235 UMOL/L. ON (B)(6)2023, THE PATIENT HAD A CREJ2 RESULT OF 135 UMOL/L AND A SECOND RESULT OF 135 UMOL/L. ON (B)(6)2023, THE PATIENT HAD A CREJ2 RESULT OF 57 UMOL/L AND A SECOND RESULT OF 272 UMOL/L. ON (B)(6)2023, THE PATIENT HAD A CREJ2 RESULT OF 174 UMOL/L AND A SECOND RESULT OF 80 UMOL/L. ON (B)(6)2023, THE PATIENT HAD A CREJ2 RESULT OF 81 UMOL/L AND A SECOND RESULT OF 63 UMOL/L. ON (B)(6)2023, THE PATIENT HAD A CREJ2 RESULT OF 57 UMOL/L. ON (B)(6)2023, THE PATIENT HAD A CREJ2 RESULT OF 62 UMOL/L. ON (B)(6)2023, THE PATIENT HAD A CREJ2 RESULT OF 53 UMOL/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18113704 ↗
• MalfunctionNov 3, 2023High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE CREAJ2 (CREATININE) RESULTS FROM THE COBAS PRO C 503 ANALYTICAL UNIT. SAMPLE 1 INITIAL RESULT WAS 3.14 MG/DL AND THE REPEAT RESULT WAS 0.84 MG/DL. SAMPLE 2 INITIAL RESULT WAS 3.04 MG/DL AND THE REPEAT RESULT WAS 0.77 MG/DL. THE REPEAT RESULTS WERE BELIEVED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18066640 ↗
• MalfunctionJun 29, 2023High Test Results; High Test Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 2 PATIENTS' SAMPLES TESTED WITH CREATININE (CREAJ2) ASSAY ON A COBAS PRO C 503 ANALYTICAL UNIT COMPARED TO A DIFFERENT ANALYZER. SAMPLE 1: INITIAL RESULT: 1.5 MG/DL, RERUN RESULT: 0.86 MG/DL. SAMPLE 2: INITIAL RESULT: 1.21 MG/DL, RERUN RESULT: 0.8 MG/DL. THE PHYSICIAN QUESTIONED THE INITIAL RESULTS. THE REPEAT RESULTS WERE DEEMED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17227704 ↗
• MalfunctionMar 7, 2023Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED FOR K, BUN, AND CREJ2 ASSAYS. ON (B)(6)2023 AT 6:27 P.M. THE CUSTOMER RAN THE SAMPLE AND RECEIVED THE INITIAL RESULTS: K RESULT: 6.5 MMOL/L, BUN RESULT: 37 MG/DL, CREJ2 RESULT: 8.9 MG/DL. THE INITIAL RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY WHERE THE PHYSICIAN QUESTIONED THE BUN RESULT AND THE LABORATORY RERAN THE SAMPLE. THE CUSTOMER RERAN THE SAMPLE AND RECEIVED THE FOLLOWING RESULTS: K RESULT: 5.0 MMOL/L, BUN RESULT: 20 MG/DL, CREJ2 RESULT: 3.0 MG/DL. THIS MEDWATCH WILL APPLY TO BUN AND CREJ2 ASSAYS FROM THE COBAS PRO C503 ANALYTICAL UNIT. PLEASE REFER TO MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(4) FOR INFORMATION RELATED TO K RESULTS FROM THE COBAS PRO ISE ANALYTICAL UNIT. THE LOT NUMBER OF THE BUN REAGENT USED WAS 663424. THE LOT NUMBER OF CREJ2 REAGENT USED WAS 567564. THE EXPIRATION DATE OF BOTH REAGENTS WAS NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16500147 ↗
• MalfunctionNov 14, 2022High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE CREJ2 CREATININE JAFFÉ GEN.2 RESULTS FOR 1 PATIENT SAMPLE ON A COBAS PRO C 503 ANALYTICAL UNIT. ON (B)(6) 2022, THE INITIAL CREJ2 RESULT WAS 2.4 MG/DL. THE RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE PATIENT'S DOCTOR QUESTIONED THE RESULT AS IT DID NOT MATCH THEIR PREVIOUS RESULT. ON 21-OCT-2022, A NEW SAMPLE WAS COLLECTED AND THE CREJ2 RESULT WAS 0.589 MG/DL. THE FIRST SAMPLE WAS REPEATED AND THE RESULT WAS 0.6 MG/DL. THE REPEAT RESULT WAS DEEMED CORRECT. THE REAGENT LOT NUMBER IS 627775. THE EXPIRATION DATE WAS REQUESTED BUT NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15792596 ↗
• MalfunctionNov 11, 2022Low Test Results; Low Test Results

  THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED FOR CREATININE JAFFE GEN.2 (CREJ2) ON A COBAS PRO C 503 ANALYTICAL UNIT. THE INITIAL RESULT WAS 0.63 MG/DL. THIS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY WHERE IT WAS QUESTIONED BY THE PHYSICIAN. THE PATIENT IS ON DIALYSIS AND THE PHYSICIAN THOUGHT THE RESULT SHOULD BE HIGHER. ON (B)(6) 2022 THE SAMPLE WAS REPEATED WITH A RESULT OF 7.91 MG/DL. THE CUSTOMER RELEASED A CORRECTED RESULT REPORT. THE CREJ2 REAGENT LOT NUMBER AND EXPIRATION DATE WERE NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15782100 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K951595. One submission often covers many models, so check the product and lot details in each record.

• Z-1675-2021 · Apr 26, 2021 · Open, Classified
  IRON GEN 2: ROCHE COBAS INTEGRA ANALYZER, REAGENT CASSETTES, Catalog#: 03183696122 - Product Usage: In vitro test for the quantitative determination of iron in human serum and plas
• Z-0100-2017 · Jul 15, 2016 · Terminated
  Roche COBAS INTEGRA 800 /800 CTS Analyzer Analyzer, Chemistry (Photometric, Discrete for Clinical use Product Usage: The system cobas p612 is a computer-controlled stand-alone sys
• Z-0168-2014 · Sep 16, 2013 · Terminated
  COBAS INTEGRA 800 Analyzer with software 9864.C2 Cobas. COBAS Part Numbers 28122474001, 28122474692, 04559126001, 04589459970 corresponding to the Analyzer with or without closed
• Z-0696-2013 · Nov 19, 2012 · Terminated
  Roche COBAS INTEGRA 400 and 400 plus Analyzer, an in vitro diagnostic analyzer.
• Z-0007-2009 · Jun 11, 2008 · Terminated
  Roche Diagnostics IRON2, Iron Gen. 2, COBAS INTEGRA, cobas c systems, Roche Diagnostics, Indianapolis, IN.; 03183696122. An in-vitro diagnostic reagent system intended for use on
• Z-0012-2009 · Jun 11, 2008 · Terminated
  Roche Diagnostics NAPA2, N-Acetyl-Procainamide, COBAS INTEGRA, Roche Diagnostics, Indianapolis, IN.; 20737852322. An in-vitro diagnostic reagent system intended for use on COBAS I
• Z-0667-03 · Feb 13, 2003 · Terminated
  COBAS INTEGRA Creatinine Jaffe for use on the INTEGRA 400, 700 and 800 analyzers; system ID # 0764345, catalog # 20764345