cobas 8000 c 702 Module 6473245001Recalls & reported problems

Summary

The FDA's MAUDE database contains 620 adverse event reports that list this exact device (DI 04015630930845), received between Jul 13, 2018 and May 13, 2024 — classified as 1 injury, 619 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (281 reports).

11 other recalls cover devices cleared under the same FDA submission (K100853); 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 25 most recent of 620 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 13, 2024Non Reproducible Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE CALCIUM GEN. 2 RESULTS FROM THE COBAS 8000 C702 MODULE. SAMPLE 1 INITIAL RESULT WAS 7.0 MG/DL AND THE REPEAT RESULT WAS 9.1 MG/DL. SAMPLE 2 INITIAL RESULT WAS 6.5 MG/DL AND THE REPEAT RESULT WAS 8.0 MG/DL. THE REPEAT RESULTS WERE BELIEVED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19296720 ↗
• MalfunctionFeb 29, 2024High Test Results; Device Ingredient or Reagent Problem; High Test Results; Device Ingredient or Reagent Problem

  THE INITIAL REPORTER RECEIVED QUESTIONABLE CREATININE (CREAJ2) ASSAY RESULTS FROM SIX PATIENT SAMPLES TESTED ON THE COBAS 8000 C702 MODULE. THE REPORTER WAS ABLE TO PROVIDE TWO PATIENT SAMPLES WITH DISCREPANT RESULTS. THE PATIENT SAMPLES WERE RERUN ON THEIR OTHER COBAS 8000 C702 MODULE. SAMPLE (B)(6). THE INITIAL RESULT FROM THE MODULE WAS 0.91 MG/DL. THE REPEAT RESULT FROM THE OTHER MODULE WAS 0.63 MG/DL. SAMPLE (B)(6). THE INITIAL RESULT FROM THE MODULE WAS 0.92 MG/DL. THE REPEAT RESULT FROM THE OTHER MODULE WAS 0.62 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18807134 ↗
• MalfunctionFeb 28, 2024Non Reproducible Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE CREATININE (CREP2) RESULTS FROM FOUR PATIENT SAMPLES TESTED ON A COBAS 8000 C702 MODULE. SAMPLE 01: THE INITIAL RESULT WAS 3.29 MG/DL AND THE REPEAT RESULT WAS 1.02 MG/DL. SAMPLE 02: THE INITIAL RESULT WAS 1.13 MG/DL AND THE REPEAT RESULT WAS 0.83 MG/DL. SAMPLE 03: THE INITIAL RESULT WAS 0.69 MG/DL AND THE REPEAT RESULT WAS 1.16 MG/DL. SAMPLE 04: THE INITIAL RESULT WAS 1.32 MG/DL AND THE REPEAT RESULT WAS 0.88 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18796202 ↗
• MalfunctionFeb 27, 2024High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE CREP2 CREATININE PLUS VER.2 RESULTS FOR 1 PATIENT SAMPLE ON A COBAS 8000 C702 MODULE. THE INITIAL CREP2 RESULT WAS 1.5 MG/DL. THE SAMPLE WAS REPEATED ON A SECOND ANALYZER AND THE RESULT WAS 0.67 MG/DL. THE SAMPLE WAS REPEATED AGAIN ON A THIRD ANALYZER AND THE RESULT WAS 0.65 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18790761 ↗
• MalfunctionFeb 27, 2024High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE PHOS2 PHOSPHATE (INORGANIC) VER.2 RESULTS FOR 14 PATIENT SAMPLES ON A COBAS 8000 C702 MODULE. THE CUSTOMER WAS PROMPTED TO REPEAT PATIENT SAMPLES AS THEIR EVENING QC WAS OUT OF RANGE. FOR SAMPLE 1, THE INITIAL PHOS2 RESULT WAS 1.33 MG/DL. THE SAMPLE WAS REPEATED THE NEXT DAY AND THE RESULT WAS 0.90 MG/DL. FOR SAMPLE 2, THE INITIAL PHOS2 RESULT WAS 1.3 MG/DL. THE SAMPLE WAS REPEATED THE NEXT DAY AND THE RESULT WAS 0.8 MG/DL. FOR SAMPLE 3, THE INITIAL PHOS2 RESULT WAS 2.1 MG/DL. THE SAMPLE WAS REPEATED THE NEXT DAY AND THE RESULT WAS 1.3 MG/DL. FOR SAMPLE 4, THE INITIAL PHOS2 RESULT WAS 1.95 MG/DL. THE SAMPLE WAS REPEATED THE NEXT DAY AND THE RESULT WAS 1.09 MG/DL. FOR SAMPLE 5, THE INITIAL PHOS2 RESULT WAS 1.99 MG/DL. THE SAMPLE WAS REPEATED THE NEXT DAY AND THE RESULT WAS 1.10 MG/DL. FOR SAMPLE 6, THE INITIAL PHOS2 RESULT WAS 3.64 MG/DL. THE SAMPLE WAS REPEATED THE NEXT DAY AND THE RESULT WAS 1.65 MG/DL. FOR SAMPLE 7, THE INITIAL PHOS2 RESULT WAS 2.32 MG/DL. THE SAMPLE WAS REPEATED THE NEXT DAY AND THE RESULT WAS 1.01 MG/DL. FOR SAMPLE 8, THE INITIAL PHOS2 RESULT WAS 2.79 MG/DL. THE SAMPLE WAS REPEATED THE NEXT DAY AND THE RESULT WAS 1.12 MG/

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18790752 ↗
• MalfunctionFeb 27, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT SAMPLES TESTED WITH CREATININE PLUS VER.2 (CREP2) ASSAY ON A COBAS 8000 C702 ANALYZER. INITIAL RESULT: 36.6 UMOL/L. THE PHYSICIAN QUESTIONED THE RESULT AND REQUESTED A REPEAT OF THE SAMPLE. REPEAT RESULT: 82.2 UMOL/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18788829 ↗
• MalfunctionFeb 23, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR AN UNSPECIFIED NUMBER OF PATIENT SAMPLES TESTED WITH DIFFERENT ASSAYS ON A COBAS 8000 C702 ANALYZER. DISCREPANT RESULTS FOR 1 PATIENT SERUM SAMPLE TESTED WITH GLUCOSE (GLUC3) ASSAY WERE PROVIDED. INITIAL RESULT: 28.2 MG/DL. REPEAT RESULT: 65.7 MG/DL. THE REPEAT RESULT WAS DEEMED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18768699 ↗
• MalfunctionFeb 21, 2024Non Reproducible Results; Non Reproducible Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 6 PATIENTS' SERUM/PLASMA SAMPLES TESTED WITH CREATININE GEN.2 (CREP2) ASSAY ON A COBAS 8000 C702 ANALYZER. SAMPLE 1: ON (B)(6) 2024: INITIAL RESULT: 567 UMOL/L. THIS RESULT WAS AUTO-VALIDATED. THE QUESTIONABLE RESULT WAS NOTICED BY CHANCE AND THE SAMPLE WAS THEN REPEATED ON THE SAME DAY. REPEAT RESULT: 46 UMOL/L. THE REPEAT RESULT WAS DEEMED TO BE CORRECT. SAMPLE 2: ON (B)(6) 2024: INITIAL RESULT: 112 UMOL/L. 1ST REPEAT RESULT: 70 UMOL/L. 2ND REPEAT RESULT: 72 UMOL/L. SAMPLE 3: ON (B)(6) 2024: INITIAL RESULT: 424 UMOL/L. REPEAT RESULT: 74 UMOL/L. SAMPLE 4: ON (B)(6) 2024: INITIAL RESULT: 673 UMOL/L. ON (B)(6) 2024: REPEAT RESULT: 80 UMOL/L. SAMPLE 5: ON (B)(6) 2024: INITIAL RESULT: 263 UMOL/L. ON (B)(6) 2024: REPEAT RESULT: 61 UMOL/L. SAMPLE 6: ON (B)(6) 2024: INITIAL RESULT: 180 UMOL/L. REPEAT RESULT: 93 UMOL/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18753696 ↗
• MalfunctionFeb 20, 2024Low Test Results; Low Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE CA2 RESULTS FOR MULTIPLE PATIENT SAMPLES ON A COBAS 8000 C 702 MODULE. ONE EXAMPLE WAS PROVIDED. THE INITIAL RESULT WAS 6.684 MG/DL. THE REPEATED RESULTS WERE 8.972 MG/DL AND 9.0 MG/DL. THE RESULT OF 9.0 MG/DL WAS BELIEVED TO BE CORRECT. THE SAMPLES WERE REPEATED DUE TO THE CUSTOMER NOTICING A LARGE NUMBER OF LOW RESULTS AND SAMP.C FLAGS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18743267 ↗
• MalfunctionFeb 20, 2024Low Test Results; Low Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE LOW CREP2 (CREATININE) ASSAY RESULT FOR A PATIENT SAMPLE TESTED ON COBAS 8000 C 702 MODULE. THE INITIAL RESULT WAS 63.8 MOL/L AND WAS REPEATED ON THE SAME MODULE AS 208.5 MOL/L. THE RESULT FROM A DIFFERENT SAMPLE FROM THE PATIENT TESTED WITH A DIFFERENT COBAS C 702 MODULE WAS 244.4 MOL/L. THE DISCREPANT LOW RESULT WAS NOT REPORTED OUTSIDE THE LABORATORY BECAUSE THE PATIENT'S HISTORY PREVIOUSLY GAVE VALUES BETWEEN 200-300 MOL/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18737778 ↗
• MalfunctionFeb 15, 2024High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF A QUESTIONABLE TRIGLYCERIDE RESULT FOR A PATIENT SAMPLE TESTED ON A COBAS 8000 C 702 MODULE. THE INITIAL RESULT WAS 5.59 MMOL/L AND THE REPEATED RESULT WAS 3.15 MMOL/L. THE REPEAT RESULT WAS BELIEVED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18711513 ↗
• MalfunctionFeb 15, 2024High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE CREP2 CREATININE PLUS VER.2 AND UREAL UREA/BUN RESULTS FOR 1 PATIENT SAMPLE ON A COBAS 8000 C702 MODULE. THE INITIAL CREATININE RESULT WAS 7.25 MG/DL AND THE INITIAL UREA RESULT WAS 130.2 MG/DL. THE SAMPLE WAS RE-CENTRIFUGED AND REPEATED ON THE SAME ANALYZER. THE REPEAT CREATININE RESULTS WERE 4.60 MG/DL WITH FLAG AND 4.62 MG/DL WITH FLAG AND THE REPEAT UREA RESULT WAS 89.5 MG/DL WITH FLAG. THE NEXT DAY, THE PATIENT HAD A NEW SAMPLE COLLECTED AND THE CREATININE RESULT WAS 0.84 MG/DL AND THE UREA RESULT WAS 39.60 MG/DL WITH FLAG. THE RESULTS FROM THE NEW SAMPLE WERE DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18711290 ↗
• MalfunctionFeb 14, 2024Low Test Results; Low Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE RESULTS FOR AN UNSPECIFIED NUMBER OF PATIENT SAMPLES TESTED WITH MG2 (MAGNESIUM) AND CA2 (CALCIUM) ON A COBAS 8000 C702 MODULE. EXAMPLES WERE PROVIDED FOR TWO PATIENT SAMPLES WITH DISCREPANT RESULTS. THE FIRST SAMPLE INITIALLY RESULTED IN A MAGNESIUM VALUE GREATER THAN THE HIGH END OF THE ASSAY MEASURING RANGE (> 2.0 MMOL/L). NO SPECIFIC RESULT WAS PROVIDED FOR THE INITIAL VALUE. THE SAMPLE WAS REPEATED WITH AUTOMATIC DILUTION, RESULTING IN A MAGNESIUM VALUE OF 0.8 MMOL/L. THE SAMPLE WAS ALSO REPEATED ON A SECOND ANALYZER, RESULTING IN A MAGNESIUM VALUE OF 0.8 MMOL/L. THE SECOND SAMPLE RESULTED IN CALCIUM VALUES OF 2.049 MMOL/L AND 1.661 MMOL/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18702691 ↗
• MalfunctionFeb 13, 2024False Positive Result; Low Test Results; False Positive Result; Low Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE CREJ2 RESULTS FOR APPROXIMATELY 200 PATIENT SAMPLES ON A COBAS 8000 C 702 MODULE. TWO EXAMPLES WERE PROVIDED. SAMPLE 1: THE INITIAL RESULT WAS 0.82 MG/DL. THE REPEATED RESULT WAS 1.02 MG/DL. THIS RESULT WAS BELIEVED TO BE CORRECT. SAMPLE 2: THE INITIAL RESULT WAS 0.74 MG/DL. THE REPEATED RESULT WAS 0.95 MG/DL. THE REPEATED RESULTS WERE OBTAINED ON ANOTHER C702 MODULE IN THE SAME LABORATORY. THE QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. AMENDED REPORTS WITH THE CORRECT RESULTS WERE SENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18697126 ↗
• MalfunctionFeb 13, 2024High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ASTLP ASPARTATE AMINOTRANSFERASE ACC. TO IFCC WITH PYRIDOXAL PHOSPHATE ACTIVATION AND ALTL ALANINE AMINOTRANSFERASE ACC. TO IFCC WITHOUT PYRIDOXAL PHOSPHATE ACTIVATION RESULTS FOR 3 PATIENT SAMPLES ON A COBAS 8000 C702 MODULE. THE CUSTOMER NOTICED DATA FLAGS ON MULTIPLE RESULTS WHICH PROMPTED THEM TO REPEAT PATIENT SAMPLES. FOR PATIENT 1, THE INITIAL ALT RESULT WAS 44 U/L AND THE INITIAL AST RESULT WAS 21 U/L. THE SAMPLE WAS REPEATED ON ANOTHER C702 ANALYZER AND THE REPEAT ALT RESULT WAS 15 U/L AND THE REPEAT AST RESULT WAS 17 U/L. FOR PATIENT 2, THE INITIAL ALT RESULT WAS 35 U/L AND THE INITIAL AST RESULT WAS 42 U/L. THE SAMPLE WAS REPEATED ON ANOTHER C702 ANALYZER AND THE REPEAT ALT RESULT WAS 14 U/L AND THE REPEAT AST RESULT WAS 22 U/L. FOR PATIENT 3, THE INITIAL ALT RESULT WAS 51 U/L AND THE INITIAL AST RESULT WAS 40 U/L. THE SAMPLE WAS REPEATED ON ANOTHER C702 ANALYZER AND THE REPEAT ALT RESULT WAS 11 U/L AND THE REPEAT AST RESULT WAS 17 U/L. THE REPEAT RESULTS WERE DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18695857 ↗
• MalfunctionFeb 9, 2024Low Test Results; Low Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH GLUCOSE HK GEN.3 ON A COBAS 8000 C 702 MODULE. THE SAMPLE INITIALLY RESULTED IN A GLUCOSE VALUE OF < 0.2 MMOL/L. THE SAMPLE WAS REPEATED TWICE, RESULTING IN GLUCOSE VALUES OF 5.8 MMOL/L AND 5.5 MMOL/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18676964 ↗
• MalfunctionFeb 8, 2024Low Test Results; Low Test Results

  THE INITIAL REPORTER QUESTIONED LOW RESULTS FOR MULTIPLE PATIENT SAMPLES TESTED FOR UA2 AND UREAL ON A COBAS 8000 C 702 MODULE. DISCREPANT RESULTS WERE IDENTIFIED FOR 1 PATIENT SAMPLE WHILE TROUBLESHOOTING QC ISSUES. THE INITIAL UREAL RESULT WAS 0.7 MG/DL. THE REPEAT RESULT WAS 58.1 MG/DL. THE INITIAL UA2 RESULT WAS 0.3 MG/DL. THE REPEAT RESULT WAS 3.3 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18669521 ↗
• MalfunctionFeb 7, 2024High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE GLUCOSE RESULTS FOR MANY PATIENT SAMPLES ON A COBAS 8000 C 702 MODULE. THREE EXAMPLES WERE PROVIDED. SAMPLE 1: THE INITIAL RESULT WAS 377 MG/DL AND THE REPEATED RESULT WAS 124 MG/DL. SAMPLE 2: THE INITIAL RESULT WAS 192 MG/DL AND THE REPEATED RESULT WAS 81 MG/DL. SAMPLE 3: THE INITIAL RESULT WAS 235 MG/DL AND THE REPEATED RESULT WAS 111 MG/DL. THE RESULTS WERE QUESTIONED AND REPEATED DUE TO NOT FITTING WITH THE PATIENT'S MEDICAL HISTORY. THE REPEATED RESULTS WERE OBTAINED ON ANOTHER MODULE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18658455 ↗
• MalfunctionFeb 6, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE INITIAL REPORTER COMPLAINED OF INTERMITTENT QUESTIONABLE RESULTS ON A COBAS 8000 C 702 MODULE. DISCREPANT RESULTS WERE PROVIDED FOR 3 PATIENT SAMPLES TESTED FOR EITHER CREP2 OR CA2. PATIENT (B)(6) INITIAL CREP2 RESULT WAS 128 UMOL/L. THIS RESULT FAILED A DELTA CHECK IN THE INFINITY SOFTWARE AND THE SAMPLE WAS REPEATED WITH A RESULT OF 82 UMOL/L. THE SAMPLE WAS REPEATED ON A DIFFERENT C702 MODULE WITH A RESULT OF 83 UMOL/L. PATIENT (B)(6) INITIAL CREP2 RESULT WAS 111 UMOL/L. THE REPEAT RESULT WAS 76 UMOL/L. PATIENT (B)(6) INITIAL CA2 RESULT WAS 0.75 MMOL/L. THE CLINICIANS CONTACTED THE CUSTOMER INDICATING THIS RESULT DID NOT CORRESPOND TO THE PATIENT¿S MEDICAL PROFILE. THE REPEAT RESULT WAS 2.56 MMOL/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18651957 ↗
• MalfunctionFeb 5, 2024Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY WERE HAVING RINSE UNIT ISSUES ON THEIR COBAS 8000 C702 MODULE CAUSING CONTROLS TO RECOVER OUTSIDE OF RANGE FOR MULTIPLE ASSAYS. THE ISSUE OCCURRED AFTER MAINTENANCE WAS PERFORMED ON THE RINSE MECHANISM. TWO PATIENT SAMPLES HAD DISCREPANT RESULTS WHEN TESTED WITH CA2 (CALCIUM). THE FIRST SAMPLE INITIALLY RESULTED IN A CALCIUM VALUE OF 6.8 MG/DL AND IT WAS REPEATED ON A SECOND ANALYZER, RESULTING IN A VALUE OF 9.6 MG/DL. THE SECOND SAMPLE INITIALLY RESULTED IN A CALCIUM VALUE OF 5.6 MG/DL AND IT WAS REPEATED ON A THIRD ANALYZER, RESULTING IN A VALUE OF 9.5 MG/DL. THE REPEAT VALUES WERE DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18641880 ↗
• MalfunctionJan 31, 2024Low Test Results; Low Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH UA2 (URIC ACID) ON A COBAS 8000 C 702 MODULE. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE WAS REPEATED AS THE INITIAL VALUE DID NOT AGREE WITH THE PATIENT'S CLINICAL DIAGNOSIS. THE SAMPLE INITIALLY RESULTED IN A URIC ACID VALUE OF 83.5 UMOL/L AND IT REPEATED AS 372.7 UMOL/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18613971 ↗
• MalfunctionJan 31, 2024High Test Results; High Test Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT'S SAMPLE TESTED WITH CALCIUM ASSAY AND 1 PATIENT'S SAMPLE TESTED WITH CREATININE ASSAY AND 1 PATIENT'S SAMPLE TESTED WITH TOTAL PROTEIN ASSAY ON A COBAS 8000 C702 ANALYZER. SAMPLE 1 WAS TESTED FOR CALCIUM: INITIAL RESULT: >5 MMOL/L. REPEAT RESULT: 2.22 MMOL/L. SAMPLE 2 WAS TESTED FOR CREATININE: INITIAL RESULT: OVER 1000 UMOL/L. REPEAT RESULT: 72 UMOL/L. SAMPLE 1 WAS TESTED FOR TOTAL PROTEIN: INITIAL RESULT: 208 G/L. REPEAT RESULT: AROUND 60 G/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18612934 ↗
• MalfunctionJan 30, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THERE WAS AN ALLEGATION OF QUESTIONABLE UREA RESULTS FROM THE COBAS 8000 C702 MODULE. EXAMPLE 1 INITIAL RESULT WAS 1.9 MMOL/L AND THE REPEAT RESULTS WERE 7.8 MMOL/L AND 7.8 MMOL/L. EXAMPLE 2 INITIAL RESULT WAS 1.6 MMOL/L AND THE REPEAT RESULTS WERE 11.3 MMOL/L AND 11.8 MMOL/L. EXAMPLE 3 INITIAL RESULT WAS 1 MMOL/L AND THE REPEAT RESULT WAS 20 MMOL/L. THE QUESTIONABLE RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18606287 ↗
• MalfunctionJan 30, 2024High Test Results; High Test Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE CREJ2 CREATININE JAFFÉ GEN.2 (CREJ2) RESULTS FROM TWO PATIENT SAMPLES TESTED ON THE COBAS 8000 C702 MODULE. THE REPORTER WAS ABLE TO PROVIDE ONE EXAMPLE OF DISCREPANT RESULTS: THE REPORTER WAS NOT ABLE TO SPECIFY THE ANALYZER USED FOR THE RESULTS, WHICH RESULTS WERE DEEMED CORRECT, AND IF THE ANALYZERS WERE FROM THE SAME SYSTEM. THE INITIAL RESULT FROM THEIR COBAS 1 WAS 2.03 MG/DL. THE REPEAT RESULT FROM THEIR COBAS 2 WAS 1.04 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18606275 ↗
• MalfunctionJan 29, 2024Low Test Results; Low Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE CA2 CALCIUM GEN.2 RESULTS FOR 9 PATIENT SAMPLES ON A COBAS 8000 C702 MODULE. FOR SAMPLE 1, THE INITIAL CALCIUM RESULT WAS 1.61 MG/DL. THE SAMPLE WAS REPEATED ON ANOTHER (B)(6) ANALYZER AND THE RESULT WAS 6.36 MG/DL. FOR SAMPLE 2, THE INITIAL CALCIUM RESULT WAS 8.83 MG/DL. THE SAMPLE WAS REPEATED ON ANOTHER (B)(6) ANALYZER AND THE RESULT WAS 10.83 MG/DL. FOR SAMPLE 3, THE INITIAL CALCIUM RESULT WAS 6.21 MG/DL. THE SAMPLE WAS REPEATED ON ANOTHER (B)(6) ANALYZER AND THE RESULT WAS 8.72 MG/DL. FOR SAMPLE 4, THE INITIAL CALCIUM RESULT WAS 5.56 MG/DL. THE SAMPLE WAS REPEATED ON ANOTHER (B)(6) ANALYZER AND THE RESULT WAS 8.84 MG/DL. FOR SAMPLE 5, THE INITIAL CALCIUM RESULT WAS 7.18 MG/DL. THE SAMPLE WAS REPEATED ON ANOTHER (B)(6) ANALYZER AND THE RESULT WAS 8.8 MG/DL. FOR SAMPLE 6, THE INITIAL CALCIUM RESULT WAS 5.61 MG/DL. THE SAMPLE WAS REPEATED ON ANOTHER (B)(6) ANALYZER AND THE RESULT WAS 8.0 MG/DL. FOR SAMPLE 7, THE INITIAL CALCIUM RESULT WAS 5.01 MG/DL. THE SAMPLE WAS REPEATED ON ANOTHER (B)(6) ANALYZER AND THE RESULT WAS 8.58 MG/DL. FOR SAMPLE 8, THE INITIAL CALCIUM RESULT WAS 8.29 MG/DL. THE SAMPLE WAS REPEATED ON ANOTHER (B)(6) ANALYZER AND

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18601720 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K100853. One submission often covers many models, so check the product and lot details in each record.

• Z-0754-2021 · Dec 8, 2020 · Open, Classified
  Roche cobas 8000 modular analyzer series (i.e., cobas 8000 ISE module; cobas c 502, 701, and 702 modules; and cobas e 602 and 801 modules). Chemistry Analyzer (photometric discrete
• Z-2477-2019 · Jul 18, 2019 · Terminated
  Cobas 8000 Modular Analyzer Series: cobas 8000 ISE module part Numbers : 05964075001 cobas c 701 module part Numbers : 05641489001 cobas c 702 module part Numbers : 06473245
• Z-1249-2019 · Mar 15, 2019 · Terminated
  cobas e 801 immunoassay analyzer
• Z-2136-2018 · Apr 3, 2018 · Terminated
  cobas e 801 immunoassay analyzer, cobas 8000 Modular Series The device is a fully automated, software controlled analyzer system for in vitro determination of analytes in human bo
• Z-0675-2018 · Jul 28, 2017 · Terminated
  Cobas 8000 Modular Series system; Software Version 05-02 and 06-03; UDI: 05641446001
• Z-0910-2018 · Jul 18, 2017 · Terminated
  cobas 8000 Modular Analyzer Series; Part Numbers: 1. 05964067001 cobas 8000 c 502 module
• Z-0378-2018 · Jun 29, 2017 · Terminated
  Brand Name: cobas c 6000 MODULAR Series System e 601 cobas c 8000 MODULAR Series System - e 602 Roche / Hitachi MODULAR Analytics Combination System Model/Catalog/Part Number
• Z-2049-2017 · Mar 21, 2017 · Terminated
  Sample probes associated with: cobas 6000 Series System, cobas 8000 Modular Analyzer Series, cobas c 311 analyzer cobas c 501/502 cobas c 701/702 cobas 8000 ISE Product Usage: Th
• Z-0097-2017 · Jul 15, 2016 · Terminated
  cobas 8000 Modular Analyzer Series c8000, Chemistry (Photometric, Discrete) for clinical use Modular e602: Immunoassay Analyzer Product Usage: The VS II system is a stand-alone, c
• Z-1449-2014 · Mar 13, 2014 · Terminated
  Cobas c8000 Modular Analyzer Series Cobas c502, Part Number 5964067001, a clinical chemistry analyzer intended for the in vitro quantitative / qualitative determination of analyt
• Z-1368-2013 · Apr 4, 2013 · Terminated
  Cobas 8000 modular analyzer series software version 03-01, 02, 03 and 04, impacting the cobas e 602 module only. Product Usage: Fully automated immunoassay analyzer intended for