Creatinine Jaff Gen2 6407137190Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 04015630930777), received between Jul 17, 2018 and Jan 12, 2026 — classified as 13 malfunctions.

The most frequently reported specific device problem is “High Test Results” (6 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 12, 2026High Test Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FROM 1 PATIENT'S DRAW COLLECTED IN 2 TUBES AND TESTED WITH CREATININE JAFFE GEN.2 ASSAY ON A COBAS 8000 C702 MODULE. THE PATIENT'S DRAW WAS COLLECTED IN 2 DIFFERENT TUBES: TUBE 1 AND TUBE 2. TUBE 1: INITIAL RESULT:1.98 MG/DL. THE PHYSICIAN QUESTIONED THE INITIAL RESULT, AND THE SAMPLE WAS THEN REPEATED. TUBE 2: REPEAT RESULT: 0.88 MG/DL. THE REPEAT RESULT WAS DEEMED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24038704 ↗
• MalfunctionMay 23, 2025High Test Results; High Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH CREATININE JAFFE GEN.2 ON A COBAS 8000 C 701 MODULE. THE SAMPLE INITIALLY RESULTED IN A CREATININE VALUE OF 423 UMOL/L. A NEW SAMPLE WAS COLLECTED FROM THE PATIENT ON (B)(6) 2025 AND THIS SAMPLE RESULTED IN A CREATININE VALUE OF 63.0 UMO/L. BOTH SAMPLES WERE THEN REPEATED, WITH THE FIRST SAMPLE RESULTING IN A CREATININE VALUE OF 66.7 UMOL/L AND THE SECOND SAMPLE RESULTING IN A VALUE OF 65.1 UMOL/L. THE FIRST SAMPLE WAS REPEATED ON AN UNKNOWN THIRD-PARTY PLATFORM, RESULTING IN A CREATININE VALUE OF 60 UMOL/L. THE LOW VALUES WERE DEEMED CORRECT BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22077784 ↗
• MalfunctionJan 8, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH CREATININE JAFFÉ GEN. 2 ON A COBAS 8000 C 701 MODULE. IT IS SUSPECTED THAT THE HIGH LIPEMIA IN THE SAMPLE MAY HAVE INTERFERED WITH THE ASSAY. THE AFFECTED SAMPLE HAD INTENSE LIPEMIA, WITH A LIPEMIA INDEX (L INDEX) OF 504 AND A TRIGLYCERIDE CONCENTRATION OF 2736 MG/DL. BASED ON THIS, THE CUSTOMER CENTRIFUGED THE SAMPLE, AND THE ELECTROLYTE TESTS WERE CARRIED OUT USING THE SUPERNATANT. THE DIRECTLY PROCESSED SAMPLE INITIALLY RESULTED IN A CREATININE VALUE OF 0.24 MG/DL. THE VALUE DID NOT AGREE WITH THE PATIENT'S HISTORICAL RESULTS, SO THE CUSTOMER DECIDED TO REPEAT TESTING USING THE SUPERNATANT OF THE CENTRIFUGED SAMPLE. THE REPEAT RESULT WAS 0.86 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21103227 ↗
• MalfunctionOct 10, 2024High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE TINA-QUANT CYSTATIN C GEN. 2 AND CREATININE JAFFÉ GEN. 2 RESULTS FOR 1 PATIENT ON A COBAS 8000 C 701 MODULE THAT WERE USED TO CALCULATE THE (GFR) GLOMERULAR FILTRATION RATE. THE ALLEGED CALCULATED RESULTS DID NOT FIT THE CLINICAL STATUS OF THE PATIENT. SAMPLE 1: ON (B)(6) 2024 THE CYSTATIN C RESULT WAS 2.65 MG/L. THE CALCULATED (GFR) GLOMERULAR FILTRATION RATE WAS 19.9 ML/MIN. SAMPLE 2: ON (B)(6) 2024 THE CYSTATIN C RESULT WAS 2.38 MG/L. THE CALCULATED (GFR) GLOMERULAR FILTRATION RATE WAS 22.9 ML/MIN. THE CREATININE RESULT WAS 0.88 MG/DL. THE CALCULATED (EGFR) GLOMERULAR FILTRATION RATE WAS 72 ML/MIN. SAMPLE 3: ON (B)(6) 2024 THE CYSTATIN C RESULT WAS 2.07 MG/L. THE CALCULATED (GFR) GLOMERULAR FILTRATION RATE WAS 27.6 ML/MIN. THIS MEDWATCH WILL APPLY TO THE CREATININE ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE TINA-QUANT CYSTATIN C GEN. 2 ASSAY. THE SAMPLES WERE REPEATED DUE TO THE PATIENT HAVING NO KNOWN ILLNESSES AND DID NOT TAKE ANY MEDICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20416205 ↗
• MalfunctionSep 25, 2024High Test Results; High Test Results

  THE INITIAL REPORTER RECEIVED A QUESTIONABLE CREJ2 CREATININE JAFFÉ GEN.2 (CREJ2) RESULT FROM ONE PATIENT SAMPLE TESTED ON THE COBAS 8000 C702 MODULE. ON (B)(6) 2024: THE INITIAL RESULT OF THE INITIAL PATIENT SAMPLE WAS 8.12 MG/DL. THIS RESULT DID NOT FIT THE PATIENT'S HISTORY PROMPTING THE COLLECTION OF A NEW PATIENT SAMPLE AND THE RERUN OF THE INITIAL PATIENT SAMPLE. ON (B)(6) 2024: THE RESULT OF A NEW PATIENT SAMPLE WAS 0.87 MG/DL. THIS RESULT WAS DEEMED CORRECT. THE REPEAT RESULT OF THE INITIAL PATIENT SAMPLE WAS 7.97 MG/DL. THE INITIAL RESULT WAS NOT REPORTED OUTSIDE THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20305021 ↗
• MalfunctionAug 9, 2024Unable to Obtain Readings; Unable to Obtain Readings

  THE INITIAL REPORTER RECEIVED A QUESTIONABLE CREJ2 CREATININE JAFFÉ GEN.2 (CREJ2) RESULT FROM ONE PATIENT SAMPLE TESTED ON THE COBAS 8000 C702 MODULE. THE INITIAL RESULT WAS REPORTED TO THE PATIENT. ON (B)(6) 2024: THE INITIAL RESULT FROM THE MODULE¿S LINE 2 WAS 1.54 MG/DL. ON (B)(6) 2024: THE REPEAT RESULT FROM THE MODULE¿S LINE 4 WAS 1.76 MG/DL. THIS REPEAT RESULT WAS DEEMED CORRECT. ON (B)(6) 2024: THE REPEAT RESULT FROM THE MODULE¿S LINE 2 WAS 2.01 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19949353 ↗
• MalfunctionApr 24, 2024Incorrect, Inadequate or Imprecise Result or Readings; Non Reproducible Results; Incorrect, Inadequate or Imprecise Result or Readings; Non Reproducible Results

  THERE WAS AN ALLEGATION OF A QUESTIONABLE CREATININE JAFFÉ GEN. 2 RESULT FROM THE COBAS 8000 C702 MODULE. THE INITIAL RESULT WAS 14.74 MG/DL AND THE REPEAT RESULT ON ANOTHER COBAS ANALYZER WAS 6.49 MG/DL. THE SAMPLE WAS REPEATED USING ORTHO AND THE RESULT WAS 7.90 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19171682 ↗
• MalfunctionOct 23, 2023Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT'S PLASMA SAMPLE TESTED WITH CREATININE (CREAJ2) ASSAY ON A COBAS 8000 C702 ANALYZER. INITIAL RESULT: 18 MOL/L. ON 27-SEP-2023 THE PHYSICIAN QUESTIONED THE RESULT AND THE SAMPLE WAS THEN REPEATED. 1ST RERUN RESULT: 123 MOL/L 2ND RERUN RESULT: 111 MOL/L 3RD RERUN RESULT: 121 MOL/L. AN AMENDED REPORT WITH THE CORRECT RESULT OF 121 MOL/L WAS REPORTED TO THE PHYSICIAN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17988070 ↗
• MalfunctionAug 3, 2023High Test Results; High Test Results

  THE INITIAL REPORTER QUESTIONED A HIGH RESULT FOR 1 PATIENT TESTED FOR CREJ2 CREATININE JAFFÉ GEN.2 (CREJ2) ON A COBAS 8000 C 702 MODULE. THE INITIAL RESULT WAS 4.01 MG/DL. THIS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY WHERE THE PHYSICIAN REQUESTED A RE-CHECK. A 2ND SAMPLE WAS OBTAINED AND THE RESULT WAS 0.28 MG/DL. THIS SAMPLE WAS REPEATED WITH A 1/5 DILUTION AND THE RESULT WAS 0.28 MG/DL. ON 11-JUL-2023 THE ORIGINAL SAMPLE WAS REPEATED WITH A RESULT OF [-] 0.32 MG/DL. THIS SAMPLE WAS REPEATED WITH A 1/5 DILUTION AND THE RESULT WAS 0.35 MG/DL. ON 12-JUL-2023 A 3RD SAMPLE WAS OBTAINED AND THE RESULT WAS 0.16 MG/DL. THE LOW RESULTS WERE BELIEVED TO BE CORRECT BASED ON THE CLINICAL STATUS OF THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17454801 ↗
• MalfunctionMar 6, 2023Low Test Results; Low Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE CREJ2 CREATININE JAFFÉ GEN.2 RESULTS FOR 1 PATIENT SAMPLE ON A COBAS 8000 COBAS C 701 MODULE. ON (B)(6) 2023, THE INITIAL CREJ2 RESULT FROM MODULE 2 WAS 0.18 MG/DL. ON (B)(6) 2023, THE SAMPLE WAS REPEATED ON MODULE 2 AND THE RESULT WAS 1.28 MG/DL. THE SAMPLE WAS REPEATED A SECOND TIME ON MODULE 1 AND THE RESULT WAS 1.05 MG/DL. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE REAGENT LOT IS 677539 AND THE EXPIRATION DATE IS 31-AUG-2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16486763 ↗
• MalfunctionApr 25, 2019High Test Results; High Test Results

  THIS REPORT SUMMARIZES <NOE>1</NOE> MALFUNCTION EVENT. HIGH RESULTS WERE GENERATED BY 2 COBAS 8000 COBAS C 701 MODULES. THE EVENT INVOLVED A TOTAL OF 1 PATIENT TESTED FOR CREJ2 CREATININE JAFFÉ GEN.2. THE PATIENT IS MALE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8549727 ↗
• MalfunctionAug 23, 2018Low Test Results; Low Test Results

  THE CUSTOMER STATED THAT THEY RECEIVED ERRONEOUS RESULTS FOR 11 PATIENT SAMPLES TESTED FOR CREJ2 CREATININE JAFFÉ GEN.2 ON A COBAS 8000 C 702 MODULE THAT WERE TESTED IN SEQUENCE. THE INITIAL ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLES WERE REPEATED AND THE REPEAT RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY AS THE CUSTOMER BELIEVED THERE WAS NO CLINICAL DIFFERENCE BETWEEN THE INITIAL AND REPEAT RESULTS. NO ADVERSE EVENTS WERE ALLEGED TO HAVE OCCURRED WITH THE PATIENTS. THE SERIAL NUMBER OF THE C 702 ANALYZER IS (B)(4). UPON VISUAL INSPECTION, ALL SAMPLES WERE CLEAR AND DID NOT CONTAIN FIBRIN. THE NUMBER OF TESTS LEFT IN THE REAGENT PACK WAS LOW, SO THE FIELD SERVICE REPRESENTATIVE CHANGED THE REAGENT PACK, CALIBRATED, AND THEN RAN CONTROLS. THE CUSTOMER MEASURED CONTROLS EVERY 4 HOURS TO MONITOR THE ISSUE AND NO OTHER ISSUES HAVE WERE NOTED. CALIBRATION AND CONTROLS WERE WITHIN EXPECTED RANGES, HOWEVER THE CUSTOMER REPEATED CONTROLS AFTER THE LOW PATIENT VALUES WERE NOTICED AND CONTROLS HAD LOWER VALUES SIMILAR TO THE AFFECTED PATIENT VALUES. UPON REVIEW OF THE ALARM TRACE, SOME LOW WATER BATH VOLUME ALARMS WERE OBSERVED. THERE WERE ALSO ALARMS IND

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7810385 ↗
• MalfunctionJul 17, 2018Non Reproducible Results; Non Reproducible Results

  THE CUSTOMER COMPLAINED OF QUESTIONABLE CREJ2 CREATININE JAFFÉ GEN.2 CONTROL AND PATIENT RESULTS TESTED ON A COBAS 8000 C702 MODULE. THE CUSTOMER STATED THAT THERE IS ABOUT A 25% DIFFERENCE IN THE INITIAL PATIENT AND CONTROL RESULTS COMPARED TO WHEN THE SAME SAMPLES ARE RETESTED. SPECIFIC PATIENT RESULTS WERE REQUESTED BUT WERE NOT PROVIDED. THE CUSTOMER STATED THAT THIS ISSUE OCCURS SOMETIMES WHEN THE REAGENT PACK IS ALMOST EMPTY. THE RESULTS ARE AGAIN ACCEPTABLE AFTER PERFORMING A NEW CALIBRATION. THE ERRONEOUS RESULTS WERE RELEASED OUTSIDE OF THE LABORATORY, BUT NO TREATMENT WAS PROVIDED BASED ON THE ERRONEOUS RESULTS. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE COBAS C702 SERIAL NUMBER WAS (B)(4). A FIELD ENGINEERING SPECIALIST CHANGED THE REAGENT PROBES, ADJUSTED THE REAGENT PROBES, AND READJUSTED THE CELLS. THE CUSTOMER STATED THEY BELIEVED THE CARBON DIOXIDE LEVELS IN THE LABORATORY WERE ACCEPTABLE. ON (B)(6) 2018 THE CUSTOMER REPORTED THE ISSUE WAS STILL ONGOING. NO SPECIFIC DETAILS PROVIDED. THE INVESTIGATION IS CURRENTLY ONGOING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7695280 ↗

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