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cobas e 601 Immunoassay Analyzer 04745922001Recalls & reported problems

Roche Diagnostics GmbH · Class 1

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

Quick summary

This Roche cobas e 601 is a clinical laboratory analyzer for immunoassay tests. Of the 606 reports naming it, most describe test results that could not be repeated or looked wrong, such as troponin, hepatitis and PSA tests. The reports include 2 injuries and no deaths. 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
607
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 607 adverse event reports that list this exact device (DI 04015630924714), received between Jul 12, 2018 and Sep 28, 2026 — classified as 2 injuries, 605 malfunctions.

The most frequently reported specific device problem is “Non Reproducible Results” (377 reports).

10 other recalls cover devices cleared under the same FDA submission (K060373); 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: 6 reportsDec 2023: 4 reportsJan 2024: 9 reportsFeb 2024: 5 reportsMar 2024: 5 reportsApr 2024: 4 reportsMay 2024: 4 reportsJun 2024: 5 reportsJul 2024: 6 reportsAug 2024: 5 reportsSep 2024: 8 reportsOct 2024: 7 reportsNov 2024: 11 reportsDec 2024: 6 reportsJan 2025: 13 reportsFeb 2025: 5 reportsMar 2025: 2 reportsApr 2025: 3 reportsMay 2025: 4 reportsJun 2025: 6 reportsJul 2025: 3 reportsAug 2025: 7 reportsSep 2025: 5 reportsOct 2025: 7 reportsNov 2025: 6 reportsDec 2025: 6 reportsJan 2026: 4 reportsFeb 2026: 5 reportsMar 2026: 6 reportsApr 2026: 8 reportsMay 2026: 4 reportsJun 2026: 1 reportsJul 2026: 1 reportsAug 2026: 1 reportsSep 2026: 4 reportsOct 2026: 0 reports20242025202613
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Non Reproducible Results377
  • Low Test Results210
  • High Test Results188
  • Incorrect, Inadequate or Imprecise Result or Readings70
  • Incorrect Measurement31
  • False Positive Result19
  • Mechanical Problem12
  • Output Problem12

Patient problems

  • No Clinical Signs, Symptoms or Conditions483
  • No Consequences Or Impact To Patient98
  • No Known Impact Or Consequence To Patient20
  • Insufficient Information5
  • Test Result2
  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1

Recent adverse event reports

The 25 most recent of 607 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 28, 2026Low Test Results; Non Reproducible Results

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50921536 ↗
  • MalfunctionSep 23, 2026Low Test Results; Non Reproducible Results

    There was an allegation of questionable Elecsys Troponin T Gen 5 STAT and Elecsys proBNP II STAT results for 9 patient samples on a cobas 6000 e601 module. Examples for 2 patients were provided. Patient 1's initial Troponin result was 188 ng/L.The repeat result on another e601 module was 483 ng/L.Patient 2's initial proBNP result was 116 pg/mL.The repeat result on another e601 module was 543 ng/L. The repeat results were deemed to be correct. The samples were repeated due to an abnormal QC.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50866835 ↗
  • MalfunctionSep 23, 2026High Test Results; Non Reproducible Results

    The initial reporter received questionable Elecsys Anti-Tg assay results for two patient samples tested on the cobas 6000 e601 module. Patient Sample 1The initial analysis of the patient sample yielded 282.8 IU/mL. The first repeat analysis yielded 20.63 IU/mL.The second repeat analysis yielded 16.85 IU/mL.Patient Sample 2The initial analysis of the patient sample yielded 463.3 IU/mL. The first repeat analysis yielded 18.9 IU/mL.The second repeat analysis yielded 21.5 IU/mL.The repeat results aligned with the patients' expected values.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50865646 ↗
  • MalfunctionSep 8, 2026False Positive Result

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50667562 ↗
  • MalfunctionAug 31, 2026Low Test Results; Output Problem; Non Reproducible Results

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50529059 ↗
  • MalfunctionJul 31, 2026Incorrect Measurement; High Test Results; Low Test Results; Non Reproducible Results

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50097794 ↗
  • MalfunctionJun 12, 2026False Positive Result; Non Reproducible Results

    THERE WAS AN ALLEGATION OF QUESTIONABLE TEST RESULTS FOR 4 PATIENT SAMPLES ON A COBAS 6000 E601 MODULE. THE AFFECTED ASSAYS ARE ELECSYS ANTI-HCV II AND ELECSYS HIV COMBI PT. SAMPLE 1: THE INITIAL ANTI-HCV RESULT WAS 1.770 COI (REACTIVE), AND THE REPEATED RESULT WAS 0.647COI (NON-REACTIVE). SAMPLE 2: THE INITIAL ANTI-HCV RESULT WAS 15.03 COI (REACTIVE), AND THE REPEATED RESULT WAS 0.053 COI (NON-REACTIVE). SAMPLE 3: THE INITIAL ANTI-HCV RESULT WAS 7.78 COI (REACTIVE), AND THE REPEATED RESULT WAS 0.074 COI (NON-REACTIVE). SAMPLE 4: THE INITIAL HIV COMBI PT RESULT WAS 4.59 COI (REACTIVE), AND THE REPEATED RESULT WAS 0.17 COI (NON-REACTIVE). THE SAMPLES WERE REPEATED DUE TO CALIBRATION AND QUALITY CONTROL ISSUES. THE REPEATED RESULTS WERE BELIEVED TO BE CORRECT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25488134 ↗
  • MalfunctionMay 18, 2026Incorrect, Inadequate or Imprecise Result or Readings

    THERE WAS AN ALLEGATION OF A QUESTIONABLE ELECSYS CEA ASSAY RESULT FOR A PATIENT SAMPLE TESTED ON THE COBAS 6000 E601 MODULE. THE INITIAL RESULT WAS 235 NG/ML. THE REPEAT RESULTS WERE 5 NG/ML ON BOTH OCCASIONS. THE SAMPLE WAS REPEATED AT ANOTHER LAB AND THE RESULTS WERE 225 NG/ML AND 237 NG/ML. NO ERRONEOUS RESULTS WERE REPORTED OUT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25200560 ↗
  • MalfunctionMay 13, 2026High Test Results; Low Test Results; Non Reproducible Results

    WE RECEIVED AN ALLEGATION THAT THE FREE PSA ELECSYS ASSAY RESULTS EXCEEDED THE ELECSYS TOTAL PSA ASSAY RESULTS FOR TWO PATIENT SAMPLES TESTED ON THE COBAS 6000 E601 MODULE. THIS MEDWATCH IS FOR THE FREE PSA ELECSYS ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER PT-(B)(6) FOR THE ELECSYS TOTAL PSA ASSAY. PATIENT SAMPLE 1 THE TOTAL PSA RESULT WAS 0.302 NG/ML. THE FREE PSA RESULT WAS 0.577 NG/ML. PATIENT SAMPLE 1 THE TOTAL PSA RESULT WAS 0.371 NG/ML. THE FREE PSA RESULT WAS 0.542 NG/ML.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25164157 ↗
  • MalfunctionMay 13, 2026High Test Results; Low Test Results; Non Reproducible Results

    WE RECEIVED AN ALLEGATION THAT THE FREE PSA ELECSYS ASSAY RESULTS EXCEEDED THE ELECSYS TOTAL PSA ASSAY RESULTS FOR TWO PATIENT SAMPLES TESTED ON THE COBAS 6000 E601 MODULE. THIS MEDWATCH IS FOR THE ELECSYS TOTAL PSA ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER PT-(B)(6) FOR THE FREE PSA ELECSYS ASSAY. PATIENT SAMPLE 1. THE TOTAL PSA RESULT WAS 0.302 NG/ML. THE FREE PSA RESULT WAS 0.577 NG/ML. PATIENT SAMPLE 1. THE TOTAL PSA RESULT WAS 0.371 NG/ML. THE FREE PSA RESULT WAS 0.542 NG/ML.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25163650 ↗
  • MalfunctionMay 7, 2026False Negative Result; Incorrect, Inadequate or Imprecise Result or Readings

    THERE WAS AN ALLEGATION OF FALSE-NEGATIVE ELECSYS SYPHILIS RESULTS FOR 9 PATIENT SAMPLES ON A COBAS 6000 E601 MODULE. SAMPLE 1: THE INITIAL RESULT WAS 0.225 (NEGATIVE), AND THE REPEATED RESULT WAS 70.91 (POSITIVE). SAMPLE 2: THE INITIAL RESULT WAS 0.635 (NEGATIVE), AND THE REPEATED RESULTS WERE 252.9 AND 244.8, BOTH INTERPRETED AS POSITIVE. SAMPLE 3: THE INITIAL RESULT WAS 0.12 (NEGATIVE), AND THE REPEATED RESULTS WERE 33.16 AND 31.06, BOTH INTERPRETED AS POSITIVE. SAMPLE 4: THE INITIAL RESULT WAS 0.28 (NEGATIVE), AND THE REPEATED RESULTS WERE 286.4 AND 268.4, BOTH INTERPRETED AS POSITIVE. SAMPLE 5: THE INITIAL RESULT WAS 0.105 (NEGATIVE), AND THE REPEATED RESULTS WERE 38.2 AND 35.34, BOTH INTERPRETED AS POSITIVE. SAMPLE 6: ON APRIL 28, 2026, THE INITIAL RESULT WAS 0.305 (NEGATIVE), AND THE REPEATED RESULT WAS 403.6 (POSITIVE). SAMPLE 7: ON APRIL 28, 2026, THE INITIAL RESULT WAS 0.078 (NEGATIVE), AND THE REPEATED RESULT WAS 2.48 (POSITIVE). SAMPLE 8: ON APRIL 28, 2026, THE INITIAL RESULT WAS 0.66 (NEGATIVE), AND THE REPEATED RESULT WAS 375.6 (POSITIVE). SAMPLE 9: ON APRIL 28, 2026, THE INITIAL RESULT WAS 0.575 (NEGATIVE), AND THE REPEATED RESULT WAS 453.7 (POSITIVE). THE UNIT OF ME

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25115850 ↗
  • MalfunctionApr 30, 2026False Positive Result; Non Reproducible Results

    THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS HBSAG II RESULTS FROM THE COBAS 6000 E601 MODULE. ALLEGEDLY, THERE WERE "A FEW SAMPLES" WITH HBSAG RESULTS OF APPROXIMATELY 1.37 COI (REACTIVE). SUSPECTING AN ISSUE, THE CUSTOMER RE-RAN THE TESTS ON ANOTHER COBAS E 601 SYSTEM, WHICH YIELDED NON-REACTIVE RESULTS. NO SPECIFIC DATA WAS PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25040364 ↗
  • MalfunctionApr 27, 2026High Test Results; Low Test Results; Infusion or Flow Problem; Non Reproducible Results

    THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS TROPONIN T GEN5 STAT RESULTS FROM TWO COBAS 6000 E601 MODULES FOR ONE PATIENT. THE INITIAL ZERO-HOUR RESULT FROM MODULE 1 WAS 33 NG/L. THE REPEAT RESULT ON THE SAME MODULE WAS 52.06 NG/L. A REPEAT RESULT ON MODULE 2 WAS 24.54 NG/L. ANOTHER REPEAT RESULT ON MODULE 2 WAS 34.14 NG/L. THE INITIAL 1-HOUR RESULT FROM MODULE 1 WAS 7 NG/L. THE FIRST REPEAT RESULT ON THE SAME MODULE WAS 58.69 NG/L. A REPEAT RESULT ON MODULE 2 WAS 24.04 NG/L. ANOTHER REPEAT RESULT ON MODULE 2 WAS 49.0 NG/L. THE SAMPLES WERE REPEATED BECAUSE THE CUSTOMER NOTICED THAT THE RESULTS FROM THE ZERO TO HOUR 1 WERE INCONSISTENT. THE CUSTOMER IS UNSURE WHICH RESULT IS DEEMED TO BE CORRECT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24997953 ↗
  • MalfunctionApr 24, 2026Incorrect Measurement

    THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS TROPONIN T HS STAT RESULTS FOR 2 PATIENT SAMPLES ON A COBAS 6000 E601 MODULE. SAMPLE 1: THE INITIAL RESULT WAS 44.95 PG/ML WITH A DATA ALARM (CAROVR). THE SAMPLE WAS REPEATED, AND THE RESULTS WERE 13.75 PG/ML WITH A DATA ALARM (CAROVR), AND 18.7 PG/ML. SAMPLE 2: THE INITIAL RESULT WAS 45 PG/ML, TRIGGERING A DATA ALARM (CAROVER). AFTER AUTOMATIC RERUN, THE RESULT WAS 11.3 PG/ML. THE SAMPLE WAS REPEATED AGAIN, AND THE RESULT WAS 11.4 PG/ML. THE SAMPLES WERE REPEATED BECAUSE THE RESULTS DIDN'T MATCH THE PATIENT'S CLINICAL DIAGNOSIS.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24981166 ↗
  • MalfunctionApr 11, 2026Low Test Results; Non Reproducible Results

    THERE WAS AN ALLEGATION OF A QUESTIONABLE ELECSYS HCG STAT RESULT FROM THE COBAS 6000 E601 MODULE FOR ONE PATIENT. THE INITIAL RESULT FROM THE MODULE WAS 1 MIU/ML, ACCOMPANIED BY A DATA FLAG. THE REPEAT RESULT FROM ANOTHER E601 MODULE WAS 2155 MIU/ML. THE SAMPLE WAS REPEATED BECAUSE A URINE PREGNANCY TEST WAS POSITIVE. THE REPEAT RESULT WAS DEEMED CORRECT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24847153 ↗
  • MalfunctionApr 8, 2026Low Test Results; Non Reproducible Results

    THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS HCG+BETA RESULTS FOR QC MATERIAL AND FOR ONE PATIENT FROM THE COBAS 6000 E601 MODULE. ON (B)(6) 2026, THE RESULT WAS 2710 MIU/ML. THE DOCTOR QUESTIONED AND COMPLAINED ABOUT THIS RESULT. ON (B)(6) 2026, AFTER THE SERVICE ACTIONS OF THE FIELD SERVICE ENGINEER, THE CUSTOMER REPEATED THE SAMPLE ON A COBAS E411 ANALYZER WITH A 1:50 DILUTION, AND THE RESULT WAS 15893 MIU/ML. THE REPEAT RESULT USING THE COBAS E601 WAS >10000 MIU/ML WITH A DATA FLAG. THE REPEAT RESULT WAS 17213 MIU/ML.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24818692 ↗
  • MalfunctionApr 6, 2026High Test Results; Non Reproducible Results

    THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS HCG+BETA RESULTS FROM THE COBAS 6000 E601 MODULE. SAMPLE 1: THE INITIAL RESULT WAS 43.89 MIU/ML, AND THE REPEAT RESULT WAS 85.44 MIU/ML. AFTER THE INITIAL SERVICE VISIT, THE CUSTOMER HAD FURTHER QUESTIONABLE ELECSYS HCG+BETA RESULTS. SAMPLE 2: THE INITIAL RESULT WAS 10124 MIU/ML, AND THE REPEAT RESULT THE NEXT DAY WAS 16932 MIU/ML. SAMPLE 3: THE INITIAL RESULT WAS 48090 MIU/ML, AND THE REPEAT RESULT THE NEXT DAY WAS 94281 MIU/ML. SAMPLE 4: THE INITIAL RESULT WAS 7512 MIU/ML, AND THE REPEAT RESULT THE NEXT DAY WAS 14440 MIU/ML. SAMPLE 5: THE INITIAL RESULT WAS 20806 MIU/ML, AND THE REPEAT RESULT THE NEXT DAY WAS 35142 MIU/ML. THE REPEAT RESULTS WERE BELIEVED TO BE CORRECT AND REPORTED OUTSIDE OF THE LABORATORY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24793942 ↗
  • MalfunctionApr 1, 2026Incorrect Measurement; Non Reproducible Results

    THERE WAS AN ALLEGATION OF A QUESTIONABLE RESULT WITH THE ELECSYS HCG STAT ASSAY FOR A PATIENT SAMPLE TESTED ON THE COBAS 6000 E601 MODULE. A PHYSICIAN QUESTIONED THE ACCURACY OF HCG RESULTS DUE TO EXTREME VARIABILITY OBSERVED ACROSS THREE SEPARATE BLOOD DRAWS: DRAW #1 ((B)(6) 2026): 8000 MIU/ML. DRAW #2 ((B)(6) 2026): 144 MIU/ML. DRAW #3 ((B)(6) 2026): 1884 MIU/ML.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24757234 ↗
  • MalfunctionApr 1, 2026False Positive Result; Incorrect, Inadequate or Imprecise Result or Readings

    THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS HBSAG II RESULTS FOR 3 PATIENT SAMPLES ON A COBAS 6000 E601 MODULE. SAMPLE 1: THE INITIAL RESULT WAS 1.07 COI (REACTIVE), AND THE REPEATED RESULT WAS 0.633 COI (NON-REACTIVE). THE PATIENT'S INFECTION STATUS REMAINED INCONCLUSIVE. HOWEVER, THE SAMPLE WAS DEEMED "INITIALLY REACTIVE" AND WAS RETESTED. ON (B)(6) 2026, THE SAMPLE WAS REPEATED, AND THE RESULTS WERE 14.07 COI AND 13.66 COI (BOTH REACTIVE). SAMPLE 2: ON (B)(6) 2026, THE INITIAL RESULT WAS 8.97 COI (REACTIVE), AND THE REPEATED RESULTS WERE 0.353 COI (NON-REACTIVE) AND 0.415 COI (NON-REACTIVE). SAMPLE 3: ON (B)(6) 2026, THE INITIAL RESULT WAS 19.70 COI (REACTIVE) WITH A DATA FLAG, AND THE REPEATED RESULT WAS 0.600 COI (NON-REACTIVE).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24756582 ↗
  • MalfunctionMar 30, 2026False Positive Result; High Test Results; Low Test Results; Non Reproducible Results

    THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ELECSYS HBSAG II ON A COBAS 6000 E601 MODULE. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE INITIALLY RESULTED IN AN HBSAG VALUE OF 1.2 COI (REACTIVE). THE RESULT DID NOT AGREE WITH THE PATIENT'S CLINICAL DIAGNOSIS, SO THE SAMPLE WAS REPEATED. THE REPEAT HBSAG RESULT WAS 0.58 COI (NON-REACTIVE).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24730981 ↗
  • MalfunctionMar 19, 2026False Positive Result; Pumping Problem; Non Reproducible Results

    THE INITIAL REPORTER QUESTIONED A POSITIVE RESULT FOR 1 PATIENT TESTED FOR ELECSYS HBSAG II (HBSAG II) ON A COBAS 6000 E601 MODULE. THE CUSTOMER ALLEGED A FALSE POSITIVE RESULT ON THE E601 MODULE. "DISCREPANT" RESULTS WERE OBSERVED UPON REPEAT TESTING. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. NO SPECIFIC RESULTS WERE PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24637008 ↗
  • MalfunctionMar 19, 2026Non Reproducible Results

    THERE WAS AN ALLEGATION OF QUESTIONABLE RESULTS FOR MULTIPLE ASSAYS FROM THE COBAS 6000 E601 MODULE. ESTIMATED EXAMPLES WERE PROVIDED AS FOLLOWS: FT3 RESULTS INITIALLY RESULTED AT 10 PG/ML FOR ALL PATIENTS. UPON REPEATING THE TEST WITH THE SAME REAGENT, THE RESULTS DROPPED SIGNIFICANTLY (FOR EXAMPLE, ONE SAMPLE WENT FROM 10 PG/ML TO 2.8 PG/ML). THE FT4 INITIAL RESULT WAS 28 NG/L, AND THE REPEAT RESULT WAS 11 NG/L. THE INITIAL RESULT WAS 0.8 UU/ML, AND THE REPEAT RESULT WAS 13 UU/ML.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24636843 ↗
  • MalfunctionMar 16, 2026False Positive Result

    THERE WAS AN ALLEGATION OF QUESTIONABLE POSITIVE ELECSYS HBSAG II RESULTS FOR 5 PATIENT SAMPLES ON A COBAS 6000 E601 MODULE. SAMPLE 1: THE INITIAL RESULT WAS 10.93 COI (POSITIVE), AND THE REPEATED RESULT WAS 0.66 COI (NEGATIVE). SAMPLE 2: THE INITIAL RESULT WAS 3.59 COI (POSITIVE), AND THE REPEATED RESULT WAS 0.50 COI (NEGATIVE). SAMPLE 3: THE INITIAL RESULT WAS 0.93 COI (POSITIVE), AND THE REPEATED RESULT WAS 0.40 COI (NEGATIVE). SAMPLE 4: THE INITIAL RESULT WAS 1.44 COI (POSITIVE), AND THE REPEATED RESULT WAS 0.38 COI WITH A DATA FLAG (NEGATIVE). SAMPLE 5: THE INITIAL RESULT WAS 1.47 COI (POSITIVE), AND THE REPEATED RESULT WAS 0.43 COI (NEGATIVE).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24607952 ↗
  • MalfunctionMar 13, 2026Non Reproducible Results

    THE INITIAL REPORTER RECEIVED A QUESTIONABLE ELECSYS TROPONIN T GEN 5 STAT ASSAY RESULT FROM A PATIENT SAMPLE TESTED ON THE COBAS 6000 E601 MODULE. THE INITIAL RESULT FROM THE MODULE WAS 120 PG/ML. THE REPEAT RESULT FROM THE MODULE WAS 61 PG/ML. THE REPEAT RESULT FROM ANOTHER MODULE WAS 7.06 PG/ML. THE INITIAL RESULT FROM THE MODULE WAS DEEMED HIGH, PROMPTING THE RERUN. THE REPEAT RESULT FROM THE OTHER MODULE ALIGNED WITH THE PATIENT'S CLINICAL PICTURE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24591105 ↗
  • MalfunctionMar 9, 2026Low Test Results; Non Reproducible Results

    THERE WAS AN ALLEGATION OF A QUESTIONABLE ELECSYS HCG STAT RESULT FROM THE COBAS 6000 E601 MODULE FOR ONE PATIENT. THE INITIAL RESULT WAS 24 MIU/ML, ACCOMPANIED BY A DATA FLAG. THE REPEAT RESULT WAS >10,000 MIU/ML, ACCOMPANIED BY A DATA FLAG. ANOTHER SAMPLE WAS COLLECTED AT THE SAME TIME AND HAD A RESULT OF 12996 MIU/ML. THE INITIAL RESULT WAS QUESTIONED BECAUSE THE CUSTOMER NOTICED THAT THE PATIENT WAS PREGNANT AND NOTICED THE SAMPLE SHORT ALARM THAT ACCOMPANIED THE INITIAL RESULT. THE REPEAT RESULT WAS DEEMED TO BE CORRECT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24551763 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K060373. One submission often covers many models, so check the product and lot details in each record.

  • Z-2476-2019 · Jul 18, 2019 · Terminated
    cobas e 601 module (cobas 6000 Modular Series system) Part Number: 04745922001
  • Z-1268-2018 · Dec 18, 2017 · Terminated
    c6000, Chemistry (Photometric, Discrete), for clinical use. - cobas e 601 module: Immunoassay Analyzer, Catalog Numbers: 04745922001, 05036348001, 05860652001, 04745922692, 0503634
  • Z-0909-2018 · Jul 18, 2017 · Terminated
    cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL +
  • 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-0096-2017 · Jul 15, 2016 · Terminated
    cobas 6000 Series system c6000, Chemistry (Photometric, Discrete), for clinical Use. Modular e601: Immunoassay Analyzer Product Usage: The cobas p501/p701 instrument stores primar
  • Z-1791-2014 · May 21, 2014 · Terminated
    cobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay
  • Z-1792-2014 · May 21, 2014 · Terminated
    cobas 8000 analyzer series Operators Manual Roche cobas Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay
  • Z-0542-2009 · Sep 15, 2008 · Terminated
    Roche ISE Internal Standard Gen.2 for use on Roche cobas c systems, Roche Diagnostics, Inc., Indpls., IN; Catalog no. 04522320190. Product is an in vitro diagnostic.
  • Z-0576-2008 · Dec 4, 2007 · Terminated
    Roche COBAS 6000 Clinical Chemistry analyzer; Catalog Number: 04745914001, Roche Diagnostics Corporation, Indianapolis, IN 46250.

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