cobas e 801 Immunoassay analyzer 08454345001Recalls & reported problems

Summary

The FDA's MAUDE database contains 295 adverse event reports that list this exact device (DI 07613336158456), received between Nov 27, 2019 and Feb 26, 2024 — classified as 1 injury, 294 malfunctions.

The most frequently reported specific device problem is “Non Reproducible Results” (218 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Jul 14, 2022Class IIOpen, Classified

   Software issue resulting in signals and sample test results of Pre-Wash tests being impacted. The following assays are considered impacted by the issue: Anti-HAV2, Anti-HBc IgM, IGF-1, Myogloin, Rubella IgG, and Toxo IgG.

   Z-1515-2022 · Root cause: Software design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 295 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 26, 2024Non Reproducible Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE RESULTS FROM THE COBAS E 801 ANALYTICAL UNIT AFTER PREVENTIVE MAINTENANCE WAS PERFORMED. SAMPLE 1 INITIAL VITAMIN D RESULT WAS 116 NMOL/L AND THE REPEAT RESULT WAS 75 NMOL/L. SAMPLE 2 INITIAL FT3 RESULT WAS 7.6 PMOL/L AND THE REPEAT RESULT WAS 3.8 PMOL/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18778659 ↗
• MalfunctionFeb 6, 2024Non Reproducible Results; Non Reproducible Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT'S SAMPLE TESTED WITH ELECSYS FERRITIN (FERR) ASSAY ON A COBAS E801 IMMUNOASSAY ANALYZER. THE CUSTOMER DID NOT PROVIDE SPECIFIC VALUES FOR THE RESULTS AND ALLEGED THAT THE INITIAL RESULT WAS A VERY LOW AND INCONSISTENT VALUE (0 OR 1) WHILE UPON REPEATING THE SAMPLE, THE REPEAT RESULT WAS NORMAL. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18652497 ↗
• MalfunctionFeb 2, 2024Mechanical Problem; High Test Results; Non Reproducible Results; Mechanical Problem; High Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE TROPONIN T GEN5 RESULTS FOR 1 PATIENT SAMPLE ON A COBAS E 801 MODULE. THE INITIAL RESULT WAS 511 NG/L. THE RESULT WAS REPEATED DUE TO IT BEING A CRITICAL RESULT. THE REPEATED RESULT WAS 22.1 NG/L. THE REPEATED RESULT OF 22.1 NG/L WAS BELIEVED TO BE CORRECT. THE SAMPLE WAS REPEATED ON ANOTHER E801 MODULE AND THE RESULT WAS 21.9 NG/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18634993 ↗
• MalfunctionFeb 1, 2024Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results; Non Reproducible Results; Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results; Non Reproducible Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT'S PLASMA SAMPLE TESTED WITH ELECSYS PROBNP ASSAY ON A COBAS E801 IMMUNOASSAY ANALYZER WHEN COMPARED TO A DIFFERENT COBAS E801 IMMUNOASSAY ANALYZER. INITIAL RESULT: 48.3 PG/ML. THE CUSTOMER STATED THAT THE INSTRUMENT GAVE AN ALARM FOR AN ABNORMAL LOW SIGNAL DETECTED. REPEAT RESULT: 2790 PG/ML. THE REPEAT RESULT WAS DEEMED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18627554 ↗
• MalfunctionFeb 1, 2024Low Test Results; Infusion or Flow Problem; Low Test Results; Infusion or Flow Problem

  THE INITIAL REPORTER QUESTIONED LOW RESULTS FOR MULTIPLE PATIENT SAMPLES TESTED FOR MULTIPLE ASSAYS ON A COBAS E 801 ANALYTICAL UNIT. BASED ON THE DATA PROVIDED, DISCREPANT RESULTS WERE IDENTIFIED FOR 7 PATIENT SAMPLES TESTED FOR ELECSYS CA 19-9 (CA 19-9), ELECSYS AFP ASSAY (AFP), ELECSYS CA 125 II (CA 125 II), ELECSYS CEA (CEA) AND ELECSYS HE4 (HE4). REFER TO THE ATTACHED DATA FOR THE DISCREPANT RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18627327 ↗
• MalfunctionJan 22, 2024Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Non Reproducible Results; Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF A QUESTIONABLE TROPONIN T HS ELECSYS RESULT FROM THE COBAS E 801 ANALYTICAL UNIT. THE INITIAL RESULT WAS 90.05 AND THE REPEAT RESULT FROM ANOTHER INSTRUMENT WAS 12.4. NO UNIT OF MEASURE WAS PROVDIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18551746 ↗
• MalfunctionJan 9, 2024High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS TROPONIN T ASSAY AND ELECSYS PROBNP II IMMUNOASSAY RESULTS FOR 22 PATIENT SAMPLES ON A COBAS E 801 ANALYTICAL UNIT. THE DOCTOR QUESTIONED THE INITIAL RESULTS WHICH PROMPTED THE CUSTOMER TO REPEAT THE SAMPLES. REFER TO THE ATTACHMENT TO THE MEDWATCH FOR ALL PATIENT DATA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18476833 ↗
• MalfunctionJan 4, 2024Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER QUESTIONED RESULTS FOR QC AND PATIENT SAMPLES TESTED FOR ELECSYS FOLATE III (FOLATE III) ON A COBAS E 801 ANALYTICAL UNIT. OF THE DATA PROVIDED FOR 20 PATIENT SAMPLES, THE RESULTS FOR 6 PATIENT SAMPLES WERE DISCREPANT. THE CUSTOMER RAN THE PATIENT SAMPLES ON THE E801 ANALYZER IN QUESTION (ANALYZER 5) AND 2 OTHER ANALYZERS (ANALYZER 2 AND ANALYZER 3). PATIENT 1 RESULT FROM ANALYZER 5 WAS 8.65 NG/ML. THE REPEAT RESULT FROM ANALYZER 2 WAS 5.51 NG/ML. THE REPEAT RESULT FROM ANALYZER 3 WAS 5.26 NG/ML. PATIENT 2 RESULT FROM ANALYZER 5 WAS 2.18 NG/ML. THE REPEAT RESULT FROM ANALYZER 2 WAS 3.36 NG/ML. THE REPEAT RESULT FROM ANALYZER 3 WAS 3.28 NG/ML. PATIENT 3 RESULT FROM ANALYZER 5 WAS 3.52 NG/ML. THE REPEAT RESULT FROM ANALYZER 2 WAS 5.13 NG/ML. THE REPEAT RESULT FROM ANALYZER 3 WAS 4.53 NG/ML. PATIENT 4 RESULT FROM ANALYZER 5 WAS 3.91 NG/ML. THE REPEAT RESULT FROM ANALYZER 2 WAS 5.24 NG/ML. THE REPEAT RESULT FROM ANALYZER 3 WAS 4.31 NG/ML. PATIENT 5 RESULT FROM ANALYZER 5 WAS 3.77 NG/ML. THE REPEAT RESULT FROM ANALYZER 2 WAS 5.01 NG/ML. THE REPEAT RESULT FROM ANALYZER 3 WAS 4.1 NG/ML. ON (B)(6) 2023 THE SAMPLE FOR PATIENT 1 WAS REPEATED ANALYZER 5 WITH A RESULT OF 8

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18443930 ↗
• MalfunctionDec 28, 2023Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER QUESTIONED THE RESULTS FOR MULTIPLE PATIENT SAMPLES AND MULTIPLE ASSAYS ON A COBAS E 801 ANALYTICAL UNIT. OF THE DATA PROVIDED FOR 9 PATIENT SAMPLES, DISCREPANT RESULTS WERE IDENTIFIED FOR 7 PATIENT SAMPLES TESTED FOR ELECSYS FERRITIN (FERRITIN), ELECSYS VITAMIN B12 II (VITAMIN B12 II) OR ELECSYS VITAMIN D TOTAL III (VITAMIN D TOTAL III). THE UNITS OF MEASURE FOR FERRITIN AND VITAMIN D TOTAL III WERE NOT PROVIDED. PATIENT 1 INITIAL FERRITIN RESULT WAS 18. THE REPEAT RESULTS WERE 315 AND 320. PATIENT 2 INITIAL VITAMIN B12 II RESULT WAS < 100 PG/ML. THE REPEAT RESULTS WERE 551 PG/ML AND 517 PG/ML. PATIENT 3 INITIAL FERRITIN RESULT WAS 369. THE REPEAT RESULTS WERE 628 AND 652. PATIENT 4 INITIAL VITAMIN D TOTAL III RESULT WAS 22. THE REPEAT RESULT WAS 65.7 PATIENT 5 INITIAL VITAMIN D TOTAL III RESULT WAS 61.2. THE REPEAT RESULT WAS 25.8. PATIENT 6 INITIAL VITAMIN D TOTAL III RESULT WAS 31.1. THE REPEAT RESULT WAS 151. PATIENT 7 INITIAL VITAMIN B12 II RESULT WAS 330 PG/ML. THE REPEAT RESULT WAS 0.992 PG/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18415770 ↗
• MalfunctionDec 18, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THERE WAS AN ALLEGATION OF QUESTIONABLE RESULTS FROM THE COBAS E 801 ANALYTICAL UNIT. EXAMPLE 1 INITIAL PROBNP RESULT WAS 221 NG/L AND THE REPEAT RESULT WAS 473 NG/L. EXAMPLE 2 INITIAL FOLATE RESULT WAS 2.47 NG/ML AND THE REPEAT RESULT WAS 9.85 NG/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18347893 ↗
• MalfunctionDec 18, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THERE WAS AN ALLEGATION OF QUESTIONABLE FERRITIN ELECSYS E2G RESULTS FOR QC AND PATIENT SAMPLES FROM THE COBAS E 801 ANALYTICAL UNIT. FOR ONE PATIENT SAMPLE, THE INITIAL RESULT WAS 4.33 NG/ML AND THE REPEAT RESULT ON (B)(6)2023 WAS 19.3 NG/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18347473 ↗
• MalfunctionDec 18, 2023Incorrect Measurement; Incorrect, Inadequate or Imprecise Result or Readings; Non Reproducible Results; Incorrect Measurement; Incorrect, Inadequate or Imprecise Result or Readings; Non Reproducible Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS VITAMIN B12 II (VITAMIN B12 II), ELECSYS VITAMIN D, ELECSYS TSH, ELECSYS FT4 IV ASSAY, ELECSYS PROBNP, ELECSYS FERRITIN AND ELECSYS FOLATE RESULTS FROM SEVEN PATIENT SAMPLES TESTED ON THE COBAS E 801 ANALYTICAL UNIT. THE INITIAL RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. SAMPLE (B)(6). THE INITIAL VIT B12 RESULT WAS 374. THE REPEAT RESULT WAS 493. SAMPLE (B)(6). THE INITIAL VIT B12 RESULT WAS <100 (NOT REPORTED OUTSIDE THE LABORATORY). THE REPEAT RESULT WAS 268. ON 22-NOV-2023, THE INITIAL FERRITIN RESULT WAS 3.77. ON 23-NOV-2023, THE REPEAT RESULT WAS 17. ON 22-NOV-2023, THE INITIAL VIT D RESULT WAS 42.9. ON 23-NOV-2023, THE REPEAT RESULT WAS 78.9. ON 22-NOV-2023, THE INITIAL TSH RESULT WAS 1.04. ON 23-NOV-2023, THE REPEAT RESULT WAS 1.53 (THE REFERENCE RANGES WERE NOT PROVIDED). SAMPLE (B)(6) ON 22-NOV-2023, THE INITIAL VIT D RESULT WAS 46.9. ON 23-NOV-2023, THE REPEAT RESULT WAS 79.2. SAMPLE (B)(6) ON 22-NOV-2023, THE INITIAL PRO-BNP RESULT WAS 89.6. ON 23-NOV-2023, THE REPEAT RESULT WAS 536. SAMPLE (B)(6) ON 22-NOV-2023, THE INITIAL PRO-BNP RESULT WAS 66. ON 23-NOV-2023, THE REPEAT RESULT WAS 1228. ON 22-NOV-2023, THE INI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18347192 ↗
• MalfunctionDec 18, 2023False Negative Result; False Negative Result

  THE INITIAL REPORTER STATED THEY RECEIVED A QUESTIONABLE RESULT FOR ONE PATIENT SAMPLE TESTED WITH THE ELECSYS ANTI-HCV II IMMUNOASSAY ON A COBAS E 801 ANALYTICAL UNIT. THE SAMPLE INITIALLY RESULTED IN AN ANTI-HCV VALUE OF 18.1 COI (REACTIVE). THE SAMPLE WAS REPEATED TWICE, RESULTING IN VALUES OF 39.8 COI (REACTIVE) AND 0.319 COI (NON-REACTIVE). THE SAMPLE WAS REPEATED TWICE ON A SECOND ANALYZER ON (B)(6) 2023, RESULTING IN ANTI-HCV VALUES OF 44.1 COI (REACTIVE) AND 40.5 COI (REACTIVE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18343788 ↗
• MalfunctionDec 15, 2023Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ELECSYS PROLACTIN II ON A COBAS E 801 ANALYTICAL UNIT. THE SAMPLE INITIALLY RESULTED IN A PROLACTIN VALUE OF 870 UIU/ML. THE SAMPLE WAS TREATED WITH POLYETHYLENE GLYCOL (PEG) AND REPEATED. THE RESULT WAS HIGHER THAN THE INITIAL VALUE. NO SPECIFIC VALUE WAS PROVIDED. SINCE THE PEG TREATED VALUE WAS HIGHER, THE SAMPLE WAS REPEATED TWO ADDITIONAL TIMES ON (B)(6) 2023, RESULTING IN PROLACTIN VALUES OF 1430 UIU/ML AND 1416 UIU/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18334878 ↗
• MalfunctionDec 12, 2023Output Problem; Non Reproducible Results; Output Problem; Non Reproducible Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT'S SAMPLE TESTED WITH ELECSYS TROPONIN ASSAY ON A COBAS E801 IMMUNOASSAY ANALYZER. INITIAL RESULT: 5.39. 1ST REPEAT RESULT: 10.030. 2ND REPEAT RESULT: 6.19. THE UNITS OF MEASUREMENT WERE NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18314342 ↗
• MalfunctionDec 12, 2023Output Problem; Non Reproducible Results; Output Problem; Non Reproducible Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT'S SAMPLE TESTED WITH ELECSYS TROPONIN ASSAY ON A COBAS E801 IMMUNOASSAY ANALYZER. INITIAL RESULT: 7.10, 1ST REPEAT RESULT: 13.60, 2ND REPEAT RESULT: 5.20, THE UNITS OF MEASUREMENT WERE NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18314341 ↗
• MalfunctionDec 11, 2023Break; Failure to Deliver; Material Integrity Problem; Non Reproducible Results; Break; Failure to Deliver; Material Integrity Problem; Non Reproducible Results

  THERE WAS AN ALLEGATION OF A QUESTIONABLE FT4 RESULT FROM THE COBAS E 801 ANALYTICAL UNIT. THE INITIAL RESULT WAS 100 PMOL/L WITH A DATA FLAG. THE REPEAT RESULT WAS 16 PMOL/L WHICH WAS BELIEVED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18302093 ↗
• MalfunctionDec 11, 2023High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS CA 19-9 IMMUNOASSAY RESULTS FOR 1 PATIENT SAMPLE ON A COBAS E 801 ANALYTICAL UNIT. THE INITIAL CA 19-9 RESULT WAS 99 U/ML. THE SAMPLE WAS REPEATED ON THE SAMPLE ANALYZER AND THE RESULT WAS 7 U/ML. THE CUSTOMER REPEATED THE SAMPLE 3 OR 4 TIMES ON ANOTHER ANALYZER AND THE RESULTS WERE 7 U/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18301700 ↗
• MalfunctionDec 5, 2023High Test Results; High Test Results

  THE INITIAL REPORTER COMPLAINED OF DISCREPANT HIGH RESULTS FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS CEA (CEA) ON A COBAS E 801 ANALYTICAL UNIT. ON (B)(6) 2023 THE RESULT FROM THE E801 ANALYZER IN QUESTION WAS 0.99 NG/ML. ON (B)(6) 2023 THE REPEAT RESULT ON A DIFFERENT E801 ANALYZER WAS 0.79 NG/ML. ON (B)(6) 2023 THE SAMPLE WAS REPEATED ON THE E801 ANALYZER IN QUESTION WITH A RESULT OF 2.31 NG/ML. THE SAMPLE WAS REPEATED ON THIS ANALYZER WITH A RESULT OF 1.03 NG/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18268827 ↗
• MalfunctionDec 5, 2023Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS FERRITIN (FERRITIN) RESULTS FROM THREE PATIENT SAMPLES TESTED ON THE COBAS E 801 ANALYTICAL UNIT. THE REPORTER FOUND QC ERRORS ON SEVERAL ASSAYS PROMPTING THE RERUN OF THE PATIENT SAMPLES. SAMPLE 1 THE INITIAL RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE INITIAL RESULT WAS 26.5 NG/ML. THE REPEAT RESULT WAS 150 NG/ML. THE REPEAT RESULT WAS DEEMED CORRECT.  SAMPLE 2 THE INITIAL RESULT WAS <0.5 NG/ML. THE REPEAT RESULT WAS 25 NG/ML. SAMPLE 3 THE INITIAL RESULT WAS <0.5 NG/ML. THE REPEAT RESULT WAS 47 NG/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18267102 ↗
• MalfunctionDec 5, 2023Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER RECEIVED A QUESTIONABLE ELECSYS TSH RESULT FROM ONE PATIENT SAMPLE TESTED ON THE COBAS E 801 ANALYTICAL UNIT. THE INITIAL RESULT WAS 0.0194 UIU/ML. THE REPEAT RESULT WAS 0.331 UIU/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18265362 ↗
• MalfunctionDec 1, 2023Imprecision; Calibration Problem; Imprecision; Calibration Problem

  THE INITIAL REPORTER STATED QC RESULTS WERE OUT OF THE ACCEPTABLE RANGE ON A COBAS E 801 ANALYTICAL UNIT AND QUESTIONED LOW RESULTS FOR AN UNSPECIFIED NUMBER OF PATIENT SAMPLES TESTED FOR TSH ELECSYS E2G 300 V2 (TSH), AFP, INSULIN, AND C-PEPTIDE. DISCREPANT RESULTS WERE PROVIDED FOR C-PEPTIDE AND TSH. IT IS UNCLEAR WHETHER THE RESULTS ARE FOR 1 PATIENT SAMPLE OR DIFFERENT PATIENT SAMPLES. THE INITIAL C-PEPTIDE RESULT WAS <0.1 NG/ML. THE REPEAT RESULT WAS 1.34 NG/ML. THE INITIAL TSH RESULT WAS 0.0812 MIU/L. THE REPEAT RESULT WAS 1.23 MIU.L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18248550 ↗
• MalfunctionDec 1, 2023Non Reproducible Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF A QUESTIONABLE CEA ELECSYS E2G RESULT FROM THE COBAS E 801 ANALYTICAL UNIT. THE INITIAL RESULT WAS 6.74 NG/ML AND WAS REPORTED OUTSIDE OF THE LABORATORY TO THE PATIENT WHO COMPLAINED ABOUT THE RESULT. ON 13-NOV-2023, THE SAME SAMPLE WAS REPEATED AND THE RESULT WAS 0.837 NG/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18248190 ↗
• MalfunctionNov 29, 2023High Test Results; High Test Results

  THE INITIAL REPORTER QUESTIONED HIGH RESULTS FOR DIFFERENT PATIENTS AND MULTIPLE PARAMETERS ON A COBAS E 801 ANALYTICAL UNIT. APPROXIMATE DISCREPANT HIGH RESULTS WERE PROVIDED FOR 2 PATIENT SAMPLES TESTED FOR ELECSYS FT4 IV (FT4 IV) AND ELECSYS VITAMIN D TOTAL III (VITAMIN D TOTAL III). PATIENT 1: FOR FT4 IV THE APPROXIMATE RESULTS WERE 40 PMOL/L AND 20 PMOL/L. FOR VITAMIN D TOTAL III THE APPROXIMATE RESULTS WERE 440 NG/ML AND 100 NG/ML. PATIENT 2: FOR FT4 IV THE APPROXIMATE RESULTS WERE 60 PMOL/L AND 20 PMOL/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18230633 ↗
• MalfunctionNov 27, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 5 PATIENTS' SAMPLES TESTED WITH ELECSYS ESTRADIOL ASSAY ON A COBAS E801 IMMUNOASSAY ANALYZER WHEN COMPARED TO A DIFFERENT ANALYZER. SAMPLE 1 (PATIENT 1): INITIAL RESULT: >3000 PG/ML (ACCOMPANIED BY A DATA FLAG). 1ST REPEAT RESULT: 47.4 PG/ML. 2ND REPEAT RESULT: 949 PG/ML. SAMPLE 2 (PATIENT 2): INITIAL RESULT: >3000 PG/ML (ACCOMPANIED BY A DATA FLAG). 1ST REPEAT RESULT: 179 PG/ML. 2ND REPEAT RESULT: 915 PG/ML. SAMPLE 3 (PATIENT 3): INITIAL RESULT: >3000 PG/ML (ACCOMPANIED BY A DATA FLAG). 1ST REPEAT RESULT: 275 PG/ML. 2ND REPEAT RESULT: 456 PG/ML. SAMPLE 4 (PATIENT 4): INITIAL RESULT: >3000 PG/ML (ACCOMPANIED BY A DATA FLAG). 1ST REPEAT RESULT: 24 PG/ML. 2ND REPEAT RESULT: 253 PG/ML. SAMPLE 5 (PATIENT 5): INITIAL RESULT: >3000 PG/ML (ACCOMPANIED BY A DATA FLAG). 1ST REPEAT RESULT: 23.7 PG/ML. 2ND REPEAT RESULT: 1259 PG/ML. THE INITIAL RESULTS OF >3000 PG/ML (ACCOMPANIED BY A DATA FLAG) PROMPTED THE REPEAT OF THE SAMPLES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18210903 ↗