cobas e 411 Immunoassay Analyzer 04775279001Recalls & reported problems

Summary

The FDA's MAUDE database contains 533 adverse event reports that list this exact device (DI 04015630937103), received between Jul 11, 2018 and Sep 29, 2026 — classified as 4 injuries, 529 malfunctions.

The most frequently reported specific device problem is “Non Reproducible Results” (270 reports).

6 other recalls cover devices cleared under the same FDA submission (K961481); 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 533 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026High Test Results; Non Reproducible Results

  There was an allegation of questionable Elecsys Estradiol III Assay results for 2 patient samples on a cobas e 411 analyzer (disk system). Patient 1's initial result was 680.8 pg/mL.The repeat results were 51.72 pg/mL and 61.05 pg/mL.Patient 2's initial result on 09-Sep-2026 was 166.7 pg/mL.The repeat result was 52.57 pg/mL. The repeat results were deemed to be correct, as the initial high results did not match clinical expectations.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50931704 ↗
• MalfunctionSep 25, 2026High Test Results; Low Test Results; Non Reproducible Results

  The initial reporter received questionable Elecsys HCG STAT and Elecsys Troponin T hs STAT assay results for multiple patient samples tested on the cobas e 411 analyzer (disk system).The following patient samples with discrepant results were provided:Patient Sample 1HCG Initial analysis of the patient sample yielded <1 mIU/mL.Repeat analysis yielded 542 and 534 mIU/mL.Patient Sample 2Troponin T hs Initial analysis of the patient sample yielded 22 ng/L.Repeat analysis yielded 9 ng/L.Patient Sample 3Troponin T hs Initial analysis of the patient sample yielded 25 ng/L.Repeat analysis yielded 6 ng/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50899601 ↗
• MalfunctionSep 18, 2026High Test Results; Non Reproducible Results

  The initial reporter received questionable Elecsys Estradiol III Assay results for two patient samples tested on the cobas e 411 analyzer (disk system).Sample 1: Initial analysis yielded a result of 815.9 pg/mL.Repeat analysis yielded a result of <5 pg/mL.Sample 2: Initial analysis yielded a result of >3000 pg/mL with a data flag.Repeat analysis yielded a result of <5 pg/mL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50817046 ↗
• MalfunctionSep 10, 2026High Test Results; Low Test Results; Non Reproducible Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50721073 ↗
• MalfunctionAug 21, 2026False Positive Result

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50375921 ↗
• MalfunctionAug 17, 2026Low Test Results; Non Reproducible Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50287742 ↗
• MalfunctionMay 27, 2026Suction Problem; High Test Results; Low Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF A QUESTIONABLE ELECSYS ESTRADIOL III ASSAY RESULT FROM THE COBAS E 411 ANALYZER (DISK SYSTEM) FOR 1 PATIENT. THE INITIAL RESULT ON (B)(6) 2026 WAS 808.8 PG/ML. THE PATIENT RETURNED FOR REPEAT TESTING ON (B)(6) 2026, AND THE NEW RESULT WAS SIGNIFICANTLY LOWER; THE EXACT RESULT WAS NOT AVAILABLE. THE INITIAL SAMPLE WAS RETESTED BECAUSE OF THE DIFFERENCE IN RESULTS. THE REPEAT RESULT ON (B)(6) 2026 WAS 23.77 PG/ML. DURING AN ON-SITE INVESTIGATION, THE SAMPLE WAS REPEATED AGAIN, AND THE RESULT WAS 30.47 PG/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25305387 ↗
• MalfunctionMay 27, 2026False Positive Result

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS HIV COMBI PT RESULTS FROM THE COBAS E411 DISK ANALYZER. THE CUSTOMER ALLEGED THAT 50% OF SAMPLES TESTED HAD REACTIVE RESULTS. WHEN CONFIRMED WITH A RAPID TEST, THE SAME SAMPLES WERE NON-REACTIVE. NO SPECIFIC DATA WAS PROVDIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25304140 ↗
• MalfunctionMay 27, 2026Low Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS TROPONIN T HS STAT RESULTS FOR 1 PATIENT SAMPLE ON A COBAS E 411 ANALYZER (DISK SYSTEM). THE INITIAL RESULT WAS 15.61 NG/L. THE SAMPLE WAS REPEATED ON ANOTHER MODULE (MODULE 2), AND THE RESULT WAS 4.91 NG/L. THIS RESULT WAS CORRECT. ON (B)(6) 2026, THE SAMPLE WAS REPEATED. THE SAMPLE WAS TESTED ON THE SAME MODULE AS THE INITIAL RESULT, AND THE RESULT WAS 4.46 NG/L. THE RESULT ON MODULE 2 WAS 4.91 NG/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25302847 ↗
• MalfunctionMay 26, 2026High Test Results; Low Test Results; Non Reproducible Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 4 PATIENTS' SAMPLES TESTED WITH ELECSYS ESTRADIOL III ASSAY ON A COBAS E 411 ANALYZER (DISK SYSTEM). SAMPLE 1: INITIAL RESULT: 605.9 PG/ML (TESTED ON COBAS 2). REPEAT RESULT: 273 PG/ML (TESTED ON COBAS 1). SAMPLE 2 WAS TESTED ON (B)(6) 2026: INITIAL RESULT: 821.3 PG/ML (TESTED ON COBAS 1). REPEAT RESULT: 124.3 PG/ML (TESTED ON COBAS 2). SAMPLE 3 WAS TESTED ON (B)(6) 2026: INITIAL RESULT: 1551.2 PG/ML (TESTED ON COBAS 1). REPEAT RESULT: 55.46 PG/ML (TESTED ON COBAS 2). THE PHYSICIAN QUESTIONED THE INITIAL RESULTS AS THEY DID NOT MATCH THE PATIENTS' CLINICAL PICTURES, PROMPTING THE REPEAT OF THE SAMPLES. SAMPLE 4 WAS TESTED ON (B)(6) 2026: THE SAMPLE WAS INITIALLY TESTED AND REPEATED ON A DIFFERENT ANALYZER: INITIAL RESULT: <5.00 PG/ML. REPEAT RESULTS: 1198 PG/ML, 857 PG/ML, 197.3 PG/ML, >3000 PG/ML, 504.3 PG/ML, AND <5.00 PG/ML. LAST REPEAT RESULT: 999.1 PG/ML (TESTED ON COBAS 1).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25287144 ↗
• MalfunctionMay 11, 2026High Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS TROPONIN T HS STAT RESULTS FOR 2 PATIENT SAMPLES ON A COBAS E 411 ANALYZER (DISK SYSTEM). SAMPLE 1 HAD AN INITIAL RESULT OF 17.51 PG/ML. THE REPEAT RESULT WAS 525.4 PG/ML. THE REPEAT RESULT WAS DEEMED CORRECT. SAMPLE 2 HAD AN INITIAL RESULT OF 14.18 PG/ML WITH FLAG. THE SAMPLE WAS REPEATED TWICE AND THE RESULTS WERE 5.51 PG/ML AND 4.62 PG/ML. THE RESULT OF 5.51 PG/ML WAS DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25135858 ↗
• MalfunctionApr 24, 2026Incorrect, Inadequate or Imprecise Result or Readings

  THE INITIAL REPORTER RECEIVED A QUESTIONABLY HIGH ELECSYS TROPONIN T HS STAT RESULT FROM ONE PATIENT SAMPLE TESTED ON THE COBAS E 411 ANALYZER (DISK SYSTEM). THE INITIAL RESULT WAS 320.2 PG/ML (320 NG/L), WITH A DATA FLAG. THE REPEAT RESULT WAS 7.07 PG/ML (8 NG/L). THE REPORTER CHECKED THE PATIENT'S PREVIOUS RESULT AND FOUND IT WAS NORMAL, PROMPTING THE RERUN AND THE COLLECTION OF A NEW PATIENT SAMPLE FOR CONFIRMATION. THE NEW PATIENT SAMPLE ALSO GAVE A LOW RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24984645 ↗
• MalfunctionApr 15, 2026High Test Results; Low Test Results; Insufficient Device Problem Information; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS HCG STAT ASSAY RESULTS FOR THREE PATIENT SAMPLES TESTED ON THE COBAS E 411 ANALYZER (DISK SYSTEM). PATIENT SAMPLE 1 ON (B)(6) 2026: THE INITIAL RESULT WAS 193365 MIU/ML WITH A DATA FLAG. ON (B)(6) 2026: THE INITIAL RESULT WAS 151608 MIU/ML WITH A DATA FLAG. THE PATIENT UNDERWENT A SCAN FOR THREATENED ABORTION AND RESULT CORRELATION. THE PATIENT'S SCAN SHOWED A FETUS WITH A HEALTHY HEARTBEAT. PATIENT SAMPLE 2 ON (B)(6) 2026: THE INITIAL RESULT WAS 444.9 MIU/ML WITH A DATA FLAG. THE PATIENT QUESTIONED THE RESULT AS IT DID NOT MATCH HER CLINICAL PICTURE, AND THE HCG BETA RESULT FROM A COMPETITOR ANALYZER WAS 114000 MIU/ML. ON (B)(6) 2026: THE REPEAT RESULT WITH THE PATIENT SAMPLE AT 1:100 DILUTION WAS 121754 MIU/ML WITH A DATA FLAG. ON THE FIELD SERVICE ENGINEER'S (FSE) INITIAL SERVICE VISIT, HE INSPECTED THE ANALYZER AND PERFORMED MECHANICAL AND INSTRUMENT CHECKS. HE VERIFIED THE CONDITIONS AND ALIGNMENT OF THE PARTS, INCLUDING THE PROBES AND THE MIXER. ON HIS FOLLOW-UP SERVICE VISIT, HE REVIEWED THE QC GRAPHS, PROFICIENCY RESULTS, AND THE ANALYZER LOGS. PATIENT SAMPLE 3 ON (B)(6) 2026: THE INITIAL RESULT WAS >10000 MIU/ML WITH A DATA F

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24886110 ↗
• MalfunctionApr 9, 2026High Test Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS CORTISOL II (CORTISOL II) RESULTS FOR TWO PATIENT SAMPLES TESTED ON THE COBAS E 411 ANALYZER (DISK SYSTEM). PATIENT SAMPLE 1: THE INITIAL RESULT WAS >63 G/DL. THE REPEAT RESULT WAS 21.0 G/DL. PATIENT SAMPLE 1: THE INITIAL RESULT WAS >63 G/DL. THE REPEAT RESULT WAS 12.0 G/DL. THE INITIAL RESULTS WERE DEEMED ABNORMALLY HIGH. THE REPEAT RESULTS WERE DEEMED CORRECT, AS THEY WERE CONSISTENT WITH THE PATIENTS' PREVIOUS RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24826427 ↗
• MalfunctionApr 8, 2026Infusion or Flow Problem; Non Reproducible Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS FT4 IV, ELECSYS TSH V2, ELECSYS VITAMIN B12 II IMMUNOASSAY, AND ELECSYS FERRITIN ASSAY RESULTS FOR FOUR PATIENT SAMPLES TESTED ON THE COBAS E 411 ANALYZER (DISK SYSTEM). ELECSYS FT4 IV PATIENT SAMPLE 1 THE INITIAL RESULT IS <0.101 NG/DL. THE REPEAT RESULT IS 1.09 NG/DL. ELECSYS TSH V2 PATIENT SAMPLE 2 THE INITIAL RESULT IS 0.02 UIU/ML. THE REPEAT RESULT IS 1.85 UIU/ML. ELECSYS VITAMIN B12 II IMMUNOASSAY PATIENT SAMPLE 3 THE INITIAL RESULT IS <150 PG/ML. THE REPEAT RESULT IS 710.5 PG/ML. ELECSYS FERRITIN PATIENT SAMPLE 4 THE INITIAL RESULT IS 1.8 NG/ML. THE REPEAT RESULT IS 70.70 NG/ML. THE DOCTOR QUESTIONED THE LOW TSH RESULT, AND MULTIPLE ASSAYS HAD LOW RESULTS, PROMPTING THE RERUN. THE REPEAT RESULTS WERE DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24816652 ↗
• MalfunctionApr 6, 2026Incorrect, Inadequate or Imprecise Result or Readings

  THERE WAS AN ALLEGATION OF QUESTIONABLE RESULTS FOR ELECSYS CA 15-3 II, AND ELECSYS HIV COMBI PT ON A COBAS E 411 ANALYZER (DISK SYSTEM). ON (B)(6) 2026, THE INITIAL HIV RESULT WAS 25.17 COI, INTERPRETED AS REACTIVE THE SAMPLE WAS REPEATED, AND THE RESULT WAS 23.18 COI, INTERPRETED AS REACTIVE. ON (B)(6) 2026, A RESULT OF 4.98 COI WAS PROVIDED, INTERPRETED AS REACTIVE. ON (B)(6) 2026, A RESULT FROM AN UNKNOWN METHOD WAS PROVIDED OF 0.09 S/CO, INTERPRETED AS NON-REACTIVE. ON (B)(6) 2026, THE INITIAL CA 15-3 II RESULT WAS <1.0 U/ML. THE SAMPLE WAS REPEATED TWICE, AND THE RESULTS WERE 138 U/ML AND 32 U/ML. IT IS NOT CLEAR IF THE RESULTS FROM EACH TEST ARE FROM ONE PATIENT SAMPLE OR 2 PATIENT SAMPLES. FOR THE HIV COMBI TEST, IT IS NOT CLEAR IF ALL RESULTS ARE FROM THE SAME SAMPLE OR DIFFERENT SAMPLES. CLARIFICATION HAS BEEN REQUESTED BUT HAS NOT BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24793474 ↗
• MalfunctionApr 3, 2026Low Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS FERRITIN RESULTS FOR 2 PATIENT SAMPLES ON A COBAS E 411 ANALYZER (DISK SYSTEM). SAMPLE 1: THE INITIAL RESULT WAS 1.45 NG/ML, AND THE REPEATED RESULT WAS 63.89 NG/ML. SAMPLE 2: THE INITIAL RESULT WAS 1.33 NG/ML, AND THE REPEATED RESULT WAS 294.8 NG/ML. THE REPEATED RESULTS WERE BELIEVED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24779703 ↗
• MalfunctionApr 3, 2026False Positive Result; Incorrect, Inadequate or Imprecise Result or Readings

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED WITH ELECSYS HIV COMBI PT ASSAY ON A COBAS E 411 ANALYZER (DISK SYSTEM). THE INITIAL RESULT WAS 23.18 COI. THE 1ST REPEAT RESULT WAS 25.17 COI. ON (B)(6) 2026: THE 2ND REPEAT RESULT WAS 4.98 COI. THE SAMPLE WAS REPEATED ON THE CHEMILUMINESCENT MICROPARTICLE IMMUNOASSAY (CMIA) PLATFORM, AND THE 3RD REPEAT RESULT WAS 0.09 S/CO (NON-REACTIVE). THE SAMPLE WAS THEN TESTED FOR HIV-1 VIRAL LOAD POLYMERASE CHAIN REACTION (PCR), AND THE RESULT WAS "NOT DETECTED".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24778131 ↗
• InjuryApr 1, 2026Low Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS HCG+BETA ASSAY RESULTS FOR A PATIENT SAMPLE TESTED ON TWO COBAS E 411 ANALYZERS (DISK SYSTEM). ON (B)(6) 2026, THE INITIAL RESULT WAS 0.363 IU/L USING COBAS E 411 SN: (B)(6). THE SAME SAMPLE WAS REPEATED, AND THE RESULT WAS 0.100 IU/L, ACCOMPANIED BY A DATA FLAG. THE TEST WAS REPEATED AS THE PATIENT REPORTED THAT SHE HAD ALREADY TESTED POSITIVE WITH A CONVENTIONAL URINE TEST. ON (B)(6) 2026, A NEW SAMPLE WAS OBTAINED AND TESTED ON THE SECOND COBAS E 411 SN: (B)(6) AND THE RESULT WAS 1523 IU/L. THE ORIGINAL SAMPLE FROM (B)(6) 2026 WAS REPEATED ON THE SECOND COBAS E 411 SN: (B)(6) AND THE RESULT WAS 747.9 IU/L. REFER TO THE MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR AN ADDITIONAL SAMPLE INVOLVED IN THE EVENT.

  Patient problems: Spontaneous Abortion

  MAUDE report 24754819 ↗
• MalfunctionApr 1, 2026Incorrect, Inadequate or Imprecise Result or Readings; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS PROBNP II AND ELECSYS TROPONIN T GEN 5 STAT RESULTS FROM THE COBAS E 411 ANALYZER (DISK SYSTEM) FOR 2 PATIENTS. PATIENT 1'S INITIAL PROBNP RESULT WAS <36 PG/ML. THE REPEAT RESULT WAS 1910 PG/ML. THE REPEAT RESULT WAS DEEMED TO BE CORRECT. THE SAMPLE WAS REPEATED AFTER THE CARDIOLOGIST QUESTIONED THE INITIAL RESULT. PATIENT 2'S INITIAL TROPONIN T RESULT WAS 18 NG/L. A RESULT FROM A DIFFERENT TUBE DRAWN AT THE SAME TIME AS THE ORIGINAL SAMPLE WAS 0 NG/ML. THE CUSTOMER IS UNSURE WHICH RESULT IS CORRECT. THE SECOND SAMPLE WAS RUN AFTER THERE WAS A MISCOMMUNICATION WITH THE PHLEBOTOMIST, AND TWO SAMPLES WERE COLLECTED INSTEAD OF JUST ONE AND TESTED AT THE SAME TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24753299 ↗
• MalfunctionApr 1, 2026Low Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS HCG+BETA ASSAY RESULTS FOR A PATIENT SAMPLE TESTED ON TWO COBAS E 411 ANALYZERS (DISK SYSTEM). ON (B)(6) 2026, THE INITIAL RESULT WAS 6.02 IU/L USING COBAS E 411 SN: (B)(6). ON (B)(6) 2026, THE SAME SAMPLE WAS REPEATED ON THE SECOND COBAS E 411 SN: (B)(6) AND THE RESULT WAS 6089 IU/L. REFER TO THE MEDWATCH WITH A1 PATIENT IDENTIFIER PT (B)(6) FOR AN ADDITIONAL SAMPLE INVOLVED IN THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Spontaneous Abortion

  MAUDE report 24752685 ↗
• MalfunctionMar 30, 2026Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS PROGESTERONE III AND ELECSYS HCG STAT RESULTS FOR 2 PATIENT SAMPLES ON A COBAS E 411 ANALYZER (DISK SYSTEM). THE DOCTOR QUESTIONED THE INITIAL RESULTS WHICH PROMPTED THE CUSTOMER TO REPEAT THE PATIENT SAMPLES. ON (B)(6) 2026, SAMPLE 1 HAD AN INITIAL HCG RESULT OF <1.0 MIU/ML WITH FLAG. ON (B)(6) 2026, THE SAMPLE WAS REPEATED AND THE RESULT WAS >200 MIU/ML. ON (B)(6) 2026, SAMPLE 2 HAD AN INITIAL PROGESTERONE RESULT OF >60 NG/ML. THE SAMPLE WAS REPEATED AND THE RESULT WAS 0.287 NG/ML. THE REPEAT RESULTS WERE DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24717986 ↗
• MalfunctionMar 24, 2026Non Reproducible Results

  THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 2 PATIENT SAMPLES TESTED FOR ELECSYS VITAMIN D TOTAL III (VITAMIN D TOTAL III) AND ELECSYS VITAMIN B12 II (VITAMIN B12 II) ON A COBAS E 411 ANALYZER (DISK SYSTEM). PATIENT 1 INITIAL VITAMIN B12 II RESULT WAS 1162 PG/ML. THE REPEAT RESULT WAS 526.9 PG/ML. PATIENT 2 INITIAL VITAMIN D TOTAL III RESULT WAS 51.26 NG/ML. THE REPEAT RESULT WAS 11.79 NG/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24681680 ↗
• MalfunctionMar 23, 2026High Test Results; Non Reproducible Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED WITH ELECSYS TOTAL PSA ASSAY ON A COBAS E 411 ANALYZER (DISK SYSTEM), NOT MATCHING THE PATIENT'S PREVIOUS RESULTS. THE INITIAL RESULT WAS 2.19 NG/ML. THE PHYSICIAN QUESTIONED THE INITIAL RESULT AS IT DID NOT MATCH THE PATIENT'S PREVIOUS RESULTS AND REQUESTED A NEW SAMPLE TO BE DRAWN AND TESTED, RESULTING IN A TOTAL PSA VALUE OF 0.59 MG/ML AND CONSIDERED "UNDETECTABLE" AND BELOW THE MEASURING RANGE. THE ORIGINAL SAMPLE WAS THEN REPEATED, AND THE REPEAT RESULT WAS <0.014 NG/ML (ACCOMPANIED BY A DATA FLAG). THE REPEAT RESULT MATCHED THE PATIENT'S PREVIOUS RESULTS. AN AMENDED REPORT WITH THE REPEAT RESULT WAS ISSUED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24669222 ↗
• MalfunctionMar 9, 2026High Test Results; Low Test Results; Non Reproducible Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS TROPONIN T HS STAT AND HCG+BETA ELECSYS ASSAY RESULTS FROM TWO PATIENT SAMPLES TESTED ON THE COBAS E 411 ANALYZER (DISK SYSTEM). PATIENT SAMPLE 1: ELECSYS TROPONIN T HS STAT, ON (B)(6) 2026: THE INITIAL RESULT WAS 18 NG/L. ON (B)(6) 2026. THE INITIAL RESULT OF A REPEAT PATIENT SAMPLE WAS 7 PG/ML WITH A DELTA FLAG. THE REPEAT RESULT OF THE REPEAT PATIENT SAMPLE AFTER RECENTRIFUGATION WAS ALSO 7 PG/ML. THE REPEAT RESULT AFTER THE INITIAL PATIENT SAMPLE WAS RECENTRIFUGED AND ALIQUOTED WAS 7.42 PG/ML OR 7 NG/L. PATIENT SAMPLE 2: HCG+BETA ELECSYS, ON (B)(6) 2026: THE INITIAL RESULT OF THE INITIAL PATIENT SAMPLE WAS 0.655 IU/L. THE RESULT OF A NEW PATIENT SAMPLE TRIGGERED A DELTA FLAG. THE REPEAT RESULT OF THE INITIAL PATIENT SAMPLE WAS >1000 IU/L WITH A DATA FLAG. THE REPEAT RESULT OF THE DILUTED PATIENT SAMPLE WAS 92835 IU/L WITH A DATA FLAG. THE REPEAT RESULTS WERE DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24550067 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K961481. One submission often covers many models, so check the product and lot details in each record.

• Z-0499-2018 · Jul 5, 2017 · Terminated
  Roche / Hitachi MODULAR Analyzer Systems-Immunoassay Analyzer-Model/Catalog/Part Number: 11568248001/11568248692 - Elecsys 2010 analyzer (disk system) and 11804014001/11804014692 -
• Z-0095-2017 · Jul 15, 2016 · Terminated
  cobas e411 Immunoassay Analyzer e411: Immunoassay Analyzer Product Usage: The cobas p501/p701 instrument stores primary and secondary sample tubes. The tubes are stored in a contr
• Z-1790-2014 · May 21, 2014 · Terminated
  Roche MODULAR ANALYTICS EVO Serum Work Area (SWA), Operator's Manual Software Version 08-02; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N). Produc
• Z-1218-2012 · Jan 31, 2012 · Terminated
  Elecsys 2010 Analyzer Software version 06-07 The Elecsys 2010 analyzer is intended for the in vitro quantitative and qualitative analysis of analytes in body fluids.
• Z-0165-2009 · Jun 24, 2008 · Terminated
  Roche/Hitachi Modular E Module immunoassay analyzer, Roche Diagnostics, Ind., IN; GMMI Nos. 04998642001 and 03617505001.
• Z-0868-2008 · Mar 21, 2008 · Terminated
  Roche/Hitachi Modular Analytics System, Modular E Module GMMI immunoassay analyzer; Catalog numbers 04998642001 and 03617505001. Intended for qualitative and quantitative in vitr