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cobas 8000 c 701 Module 5641489001Recalls & reported problems

Roche Diagnostics GmbH · Class 1

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Quick summary

This Roche cobas 8000 c 701 module, a lab chemistry analyzer, has 195 reports and no injuries or deaths. Many reports describe test results that came out too low or too high, or repeat tests that gave different answers, for tests such as calcium and glucose. No recalls name this device.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports
195
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 195 adverse event reports that list this exact device (DI 04015630928255), received between Jul 18, 2018 and Jan 29, 2025 — classified as 195 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (76 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.

Reports received per month

Nov 2023: 10 reportsDec 2023: 12 reportsJan 2024: 5 reportsFeb 2024: 7 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 1 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports20242025202612
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Low Test Results76
  • High Test Results58
  • Non Reproducible Results53
  • Incorrect, Inadequate or Imprecise Result or Readings17
  • Incorrect Measurement10
  • Mechanical Problem6
  • Leak/Splash3
  • Infusion or Flow Problem2

Patient problems

  • No Clinical Signs, Symptoms or Conditions147
  • No Consequences Or Impact To Patient23
  • No Known Impact Or Consequence To Patient19
  • Insufficient Information3
  • No Patient Involvement1
  • Test Result1

Recent adverse event reports

The 25 most recent of 195 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJan 29, 2025Low Test Results; No Apparent Adverse Event; Low Test Results; No Apparent Adverse Event

    THERE WAS AN ALLEGATION OF A QUESTIONABLE CALCIUM GEN. 2 RESULT FROM THE COBAS 8000 COBAS C 701 MODULE. THE INITIAL RESULT WAS 8.3 MG/DL, AND THE REPEAT RESULT WAS 10.3 MG/DL. THE REPEAT RESULT WAS DEEMED TO BE CORRECT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21264905 ↗
  • MalfunctionFeb 28, 2024High Test Results; High 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 701 MODULE. NO UNITS OF MEASURE WERE PROVIDED. THE SAMPLE INITIALLY RESULTED IN A GLUCOSE VALUE OF 16.900 AND IT REPEATED WITH A VALUE OF 158.000.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18796602 ↗
  • MalfunctionFeb 27, 2024Low Test Results; Low Test Results

    THE INITIAL REPORTER QUESTIONED LOW RESULTS FOR APPROXIMATELY 30 PATIENT SAMPLES AND MULTIPLE ASSAYS ON A COBAS 8000 C 701 MODULE. DISCREPANT RESULTS WERE PROVIDED FOR 1 PATIENT SAMPLE TESTED FOR CALCIUM (CA). THE INITIAL RESULT WAS 5.5 MG/DL. THE REPEAT RESULT FROM A DIFFERENT C 701 MODULE WAS 9.5 MG/DL. THE CUSTOMER STATED THE QUESTIONABLE RESULTS FOR 1-2 PATIENT SAMPLES MAY HAVE BEEN REPORTED OUTSIDE OF THE LABORATORY AND CORRECTED. THE CUSTOMER WAS NOT ABLE TO PROVIDE ANY CLARIFICATIONS ON WHICH PATIENT SAMPLES WERE REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLES WERE REPEATED DUE TO CRITICAL LOW RESULTS OR DELTA CHECKS.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18787692 ↗
  • MalfunctionFeb 27, 2024Incorrect Measurement; Incorrect Measurement

    THE INITIAL REPORTER RECEIVED A QUESTIONABLE GLUCOSE RESULT FROM ONE PATIENT SAMPLE TESTED ON THE COBAS 8000 COBAS C 701 MODULE. THE REPORTER STATED THEY ALSO RECEIVED SAMPLE AND REAGENT PIPETTER ERRORS. THE INITIAL RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE PHYSICIAN QUESTIONED THE RESULT PROMPTING THE RERUN OF THE PATIENT SAMPLE ON THEIR ALTERNATE C 701 MODULE. THE INITIAL RESULT FROM THE MODULE WAS 315 MG/DL. THE REPEAT RESULT FROM THE ALTERNATE C 701 MODULE WAS 92 MG/DL. THE REPEAT RESULT WAS DEEMED CORRECT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18787164 ↗
  • MalfunctionFeb 21, 2024Non Reproducible Results; Non Reproducible Results

    WE RECEIVED AN ALLEGATION ABOUT DISCREPANT HIGH RESULTS FOR AN UNSPECIFIED NUMBER OF PATIENTS' SAMPLES TESTED WITH CALCIUM ASSAY, ALBUMIN ASSAY, AND ALT / GPT ASSAY ON A COBAS 8000 COBAS C701 ANALYZER. EXAMPLES OF THE DISCREPANT RESULTS WERE PROVIDED. CALCIUM: HIGH RESULT: 2.64. LOW RESULT: 2.08. ALBUMIN: HIGH RESULT: 87. LOW RESULT: 42. THE SAMPLE TESTED FOR ALBUMIN WAS A SERUM/PLASMA SAMPLE. ALT/GPT: HIGH RESULT: 81. LOW RESULT: 24. THE UNITS OF MEASUREMENT WERE NOT PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18751869 ↗
  • MalfunctionFeb 12, 2024Low Test Results; Low Test Results

    THERE WAS AN ALLEGATION OF QUESTIONABLE CALCIUM (CA2) RESULTS FOR TWO PATIENT SAMPLES TESTED ON A COBAS 8000 COBAS C 701 MODULE. ON (B)(6) 2024, THE INITIAL RESULT WAS 1.65 MMOL/L, AND THE REPEAT RESULT TESTED IN ANOTHER MODULE WAS 2.25 MMOL/L. ON (B)(6) 2024, THE INITIAL RESULT WAS 1.82 MMOL/L, AND THE REPEAT RESULT TESTED IN ANOTHER MODULE WAS 2.30 MMOL/L.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18685459 ↗
  • MalfunctionFeb 7, 2024High Test Results; High Test Results

    THERE WAS AN ALLEGATION OF QUESTIONABLE GLUCOSE (GLUC3) ASSAY RESULT FOR ONE PATIENT SAMPLE TESTED ON A COBAS 8000 COBAS C 701 MODULE. THE INITIAL RESULT WAS 667 MG/DL AND THE REPEAT RESULT WAS 90 MG/DL. IT IS UNKNOWN IF THE QUESTIONABLE RESULT WAS REPORTED OUTSIDE OF THE LABORATORY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18658794 ↗
  • MalfunctionFeb 5, 2024Low Test Results; Low Test Results

    THE INITIAL REPORTER COMPLAINED OF A DISCREPANT LOW RESULT FOR 1 PATIENT SAMPLE TESTED FOR BILT3 ON A COBAS 8000 C 701 MODULE. THE INITIAL RESULT WAS 0.03 MG/DL. THE SAMPLE WAS PIPETTED FROM A MICROCUP ON A TUBE. THE REPEAT RESULT WAS 7.98 MG/DL.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18640998 ↗
  • MalfunctionJan 26, 2024Mechanical Problem; Mechanical Problem

    THERE WAS AN ALLEGATION OF QUESTIONABLE GLUCOSE AND CREATININ RESULTS FROM THE COBAS 8000 COBAS C 701 MODULE. THE INITIAL GLUCOSE RESULT WAS 590 MG/DL AND THE REPEAT RESULT WAS 111 MG/DL. THE CREATININ INITIAL RESULT WAS 7.77 MG/DL AND THE REPEAT RESULT WAS 0.91 MG/DL. THE INITIAL RESULTS WERE QUESTIONED BY THE PHYSICIAN, AND THE REPEAT RESULTS WERE BELIEVED CORRECT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18586015 ↗
  • MalfunctionJan 19, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

    THERE WAS AN ALLEGATION OF QUESTIONABLE CA2 CALCIUM GEN.2 RESULTS FOR 1 PATIENT SAMPLE ON A COBAS 8000 COBAS C 701 MODULE. THE INITIAL CA2 RESULT WAS 7.5 MMOL/L. THE SAMPLE WAS REPEATED AND THE RESULT WAS 9.7 MMOL/L.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18544841 ↗
  • MalfunctionJan 8, 2024Low Test Results; Low Test Results

    THE INITIAL REPORTER RECEIVED A QUESTIONABLE CREP2 (CREATININE) RESULT FROM ONE PATIENT SAMPLE TESTED ON THE COBAS 8000 COBAS C 701 MODULE. THE INITIAL RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THE PATIENT SAMPLE WAS RERUN ON TWO OTHER ANALYZERS: ANALYZER A AND ANALYZER B. THE INITIAL RESULT FROM THE MODULE WAS 143 UMOL/L. THE FIRST REPEAT RESULT FROM THE MODULE WAS 293 UMOL/L. THE SECOND REPEAT RESULT FROM ANALYZER A WAS 303 UMOL/L. THE THIRD REPEAT RESULT FROM ANALYZER B WAS 285 UMOL/L. THIS WAS THE REPORTED RESULT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18468969 ↗
  • MalfunctionJan 3, 2024High Test Results; High Test Results

    THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH GLUC3 (GLUCOSE) ON A COBAS 8000 C 701 MODULE. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE INITIALLY RESULTED IN A GLUCOSE VALUE OF 520 MG/DL AND IT REPEATED AS 81 MG/DL. THE REPEAT VALUE WAS DEEMED CORRECT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18440492 ↗
  • MalfunctionJan 3, 2024Low Test Results; Low Test Results

    THERE WAS AN ALLEGATION OF MULTIPLE QUESTIONABLE CA2 RESULTS ON A COBAS 8000 C 701 MODULE. THE CUSTOMER PROVIDED RESULTS FOR 2 PATIENT SAMPLES. RESULTS FROM SAMPLE 1: THE INITIAL RESULT WAS 5.37 MG/DL. THE REPEATED RESULTS WERE 9.42 MG/DL AND 9.58 MG/DL. THE REPEATED RESULTS WERE OBTAINED USING 2 OTHER C701 MODULES. THE RESULT OF 9.42 MG/DL WAS BELIEVED TO BE CORRECT. RESULTS FROM SAMPLE 2: THE INITIAL RESULT WAS 6.23 MG/DL. THE REPEATED RESULT WAS 9.83 MG/DL. THE REPEATED RESULT WAS OBTAINED USING ANOTHER C701 MODULE. THE REPEATED RESULT WAS BELIEVED TO BE CORRECT. THE ERRONEOUS RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY DUE TO BEING HELD AS CRITICAL/PANIC VALUES.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18438512 ↗
  • MalfunctionDec 22, 2023Incorrect Measurement; Incorrect Measurement

    THE INITIAL REPORTER COMPLAINED OF DISCREPANT LOW RESULTS FOR 2 PATIENT SAMPLES TESTED FOR CA2 ON A COBAS 8000 C 701 MODULE. ON (B)(6) 2023 PATIENT 1 RESULT FROM THE C701 MODULE IN QUESTION WAS 1.72 MMOL/L. THE REPEAT FROM A DIFFERENT C701 MODULE WAS 2.30 MMOL/L. ON (B)(6) 2023 PATIENT 2 RESULT FROM THE C701 MODULE IN QUESTION WAS 1.84 MMOL/L. THE REPEAT FROM A DIFFERENT C701 MODULE WAS 2.43 MMOL/L. THE CUSTOMER REPEATED THE PATIENT SAMPLES AS THE INITIAL RESULTS WERE LOW COMPARED TO THE PATIENT¿S PREVIOUS CA2 RESULTS.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18388029 ↗
  • MalfunctionDec 22, 2023High Test Results; High Test Results

    THERE WAS AN ALLEGATION OF QUESTIONABLE GLUC3 GLUCOSE HK GEN.3 RESULTS FOR 1 PATIENT SAMPLE ON A COBAS 8000 COBAS C 701 MODULE. THE INITIAL RESULT WAS 20 MG/DL. THE CUSTOMER QUESTIONED THE LOW RESULT AND REPEATED THE SAMPLE. THE SAMPLE WAS REPEATED AND THE RESULT WAS 180 MG/DL.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18384558 ↗
  • MalfunctionDec 20, 2023Low Test Results; Low Test Results

    THERE WAS AN ALLEGATION OF QUESTIONABLE CALCIUM RESULTS FROM THE COBAS 8000 COBAS C 701 MODULE. THE INITIAL RESULT WAS 7.83 MG/DL AND THE REPEAT RESULT FROM ANOTHER COBAS C701 ANALYZER WAS 10.01 MG/DL. THE REPEAT RESULT WAS BELIEVED CORRECT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18367265 ↗
  • MalfunctionDec 19, 2023Application Program Problem; Non Reproducible Results; Application Program Problem; Non Reproducible Results

    THE INITIAL REPORTER ALLEGED THE COBAS 8000 C 701 MODULE PROVIDED RESULTS FOR AN UNSPECIFIED NUMBER OF PATIENT URINE SAMPLES TESTED FOR ALBUMIN GEN.2 (ALBT2) WHEN THE REAGENT CASSETTE WAS EMPTY. AFTER LOADING THE REAGENT CASSETTE THE CUSTOMER REPORTEDLY REPEATED PATIENT SAMPLES. THE RESULTS FOR 1 PATIENT SAMPLE WERE DISCREPANT. THE CUSTOMER ALLEGES A RESULT OF 47 MG/L WAS RECEIVED WHILE THE REAGENT CASSETTE WAS EMPTY. THE REPEAT RESULT WAS 103 MG/L.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18359240 ↗
  • MalfunctionDec 18, 2023Leak/Splash; Non Reproducible Results; Leak/Splash; Non Reproducible Results

    THERE WAS AN ALLEGATION OF QUESTIONABLE RESULTS FOR MULTIPLE ASSAYS INCLUDING CALCIUM, MAGNESIUM, CREATININE, AND ALT FROM THE COBAS 8000 COBAS C 701 MODULE. NO SPECIFIC DATA COULD BE PROVIDED, BUT THE CUSTOMER STATED THE RESULTS WERE NOT CONSISTENT WITH THE PATIENT'S CLINICAL STATUS.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18344372 ↗
  • MalfunctionDec 14, 2023Low Test Results; Low Test Results

    THERE WAS AN ALLEGATION OF QUESTIONABLE RESULTS FROM THE COBAS 8000 COBAS C 701 MODULE. PATIENT 1 INITIAL CYSTATIN RESULT WAS 0.00 MG/L AND THE REPEAT RESULT WAS 0.96 MG/L. PATIENT 2 INITIAL CALCIUM RESULT WAS 1.09 MMOL/L AND THE REPEAT RESULT WAS 1.92 MMOL/L ON THE SAME ANALYZER AND 2.52 MMOL/L ON ANOTHER C701 ANALYZER. PATIENT 3 INITIAL CALCIUM RESULT WAS 1.82 MMOL/L AND THE REPEAT RESULT WAS 1.69 MMOL/L ON THE SAME ANALYZER AND 2.35 MMOL/L ON ANOTHER C701 ANALYZER. PATIENT 4 INITIAL CALCIUM RESULT WAS 1.87 MMOL/L AND THE REPEAT RESULT WAS 2.41 MMOL/L ON THE SAME ANALYZER.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18326528 ↗
  • MalfunctionDec 13, 2023Low Test Results; Low Test Results

    WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT'S SERUM SAMPLE TESTED WITH HDL-CHOLESTEROL GEN.4 (HDLC4) ASSAY AND 2 PATIENTS' SERUM SAMPLES TESTED WITH GLUCOSE HK GEN.3 (GLUC3) ASSAY ON A COBAS 8000 COBAS C701 ANALYZER. SAMPLE 1 (PATIENT 1) WAS TESTED FOR HDLC4: INITIAL RESULT: 0 MG/DL. REPEAT RESULT: 59 MG/DL. SAMPLE 2 (PATIENT 2) WAS TESTED FOR GLUC3: INITIAL RESULT: 0 MG/DL. REPEAT RESULT: 89 MG/DL. SAMPLE 3 (PATIENT 3) WAS TESTED FOR GLUC3: INITIAL RESULT: 0 MG/DL. REPEAT RESULT: 110 MG/DL. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THE ZERO RESULTS PROMPTED THE REPEAT OF THE SAMPLES. THE REPEAT RESULTS WERE DEEMED TO BE CORRECT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18317274 ↗
  • MalfunctionDec 12, 2023Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

    THERE WAS AN ALLEGATION OF QUESTIONABLE LDHI2 LACTATE DEHYDROGENASE ACC. TO IFCC VER.2 AND TPUC3 TOTAL PROTEIN URINE/CSF GEN.3 RESULTS FOR 1 PATIENT CEREBROSPINAL FLUID (CSF) SAMPLE ON A COBAS 8000 COBAS C 701 MODULE. THIS MEDWATCH WILL COVER TPUC3. REFER TO MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE LDHI2 RESULTS. THE INITIAL TOTAL PROTEIN RESULT WAS 0.1 G/L. THE REPEAT TOTAL PROTEIN RESULT WAS 46.6 G/L.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18310691 ↗
  • MalfunctionDec 12, 2023Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

    THERE WAS AN ALLEGATION OF QUESTIONABLE LDHI2 LACTATE DEHYDROGENASE ACC. TO IFCC VER.2 AND TPUC3 TOTAL PROTEIN URINE/CSF GEN.3 RESULTS FOR 1 PATIENT CEREBROSPINAL FLUID (CSF) SAMPLE ON A COBAS 8000 COBAS C 701 MODULE. THIS MEDWATCH WILL COVER LDHI2. REFER TO MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE TPUC3 RESULTS. THE INITIAL LDH RESULT WAS 2 U/L. THE REPEAT LDH RESULT WAS 202 U/L.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18310688 ↗
  • MalfunctionDec 5, 2023Non Reproducible Results; Non Reproducible Results

    THERE WAS AN ALLEGATION OF QUESTIONABLE RESULTS FROM THE COBAS 8000 COBAS C 701 MODULE. EXAMPLE 1 INITIAL ALBUMIN RESULT WAS 22.9 MG/L AND THE REPEAT RESULT WAS 30.2MG/L. EXAMPLE 2 INITIAL CREATININE RESULT WAS 66 MOL /L AND THE REPEAT RESULTS WERE 106 MOL /L AND 104 MOL /L. EXAMPLE 3 INITIAL CREATININE RESULT WAS 65 MOL /L AND THE REPEAT RESULT WAS 98 MOL /L.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18265558 ↗
  • MalfunctionDec 4, 2023Low Test Results; Low Test Results

    THE INITIAL REPORTER RECEIVED QUESTIONABLE CA2 CALCIUM GEN.2 RESULTS FROM SIX PATIENT SAMPLES TESTED ON THE COBAS 8000 COBAS C 701 MODULE. THE INITIAL RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE REPORTER STATED THAT THE QC BECAME OUT OF RANGE PROMPTING THE RERUN OF THE PREVIOUSLY REPORTED PATIENT SAMPLES ON THEIR TWO OTHER UNSPECIFIED ANALYZERS. THE REPORTER WAS ABLE TO PROVIDE TWO EXAMPLES OF QUESTIONABLE RESULTS: SAMPLE 1: THE INITIAL RESULT FROM THE MODULE WAS 7.7 MG/DL WITH A DATA FLAG "L". THE REPEAT RESULT FROM THE OTHER ANALYZER WAS 9.7 MG/DL. SAMPLE 2: THE INITIAL RESULT FROM THE MODULE WAS 7.6 MG/DL WITH A DATA FLAG "L". THE REPEAT RESULT FROM THE OTHER ANALYZER WAS 9.6 MG/DL. THE REPEAT RESULTS WERE DEEMED CORRECT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18256543 ↗
  • MalfunctionDec 1, 2023High Test Results; High Test Results

    THERE WAS AN ALLEGATION OF QUESTIONABLE RESULTS FOR MULTIPLE PATIENT SAMPLES FROM THE COBAS 8000 COBAS C 701 MODULE. EXAMPLE 1 INITIAL GLUCOSE RESULT WAS 6.293 G/L AND THE REPEAT RESULT WAS 0.934 G/L. EXAMPLE 2 INITIAL TOTAL PROTEIN RESULT WAS 1.357 G/L AND THE REPEAT RESULT WAS 0.106 G/L. EXAMPLE 3 INITIAL CREATININE RESULT WAS 1000 MOL/L AND THE REPEAT RESULT WAS 88 MOL/L.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18247964 ↗

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

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