cobas c 703 analytical unit 09502971001Recalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 07613336200544), received between Apr 1, 2026 and Sep 24, 2026 — classified as 37 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (14 reports).

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 37 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Incorrect, Inadequate or Imprecise Result or Readings

  There was an allegation of questionable Lactate Dehydrogenase acc. to IFCC ver.2 (LDH) results for approximately 7 patient samples on a cobas c 703 analytical unit. Provided are three representative examples. Patient 1's initial result was 288 U/L, and the repeat result was 141 U/L.Patient 2's initial result on 18-Aug-2026 was 241 U/L, and the repeat result was 129 U/L.Patient 3's initial result on 18-Aug-2026 was 307 U/L, and the repeat result was 185 U/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50888725 ↗
• MalfunctionSep 8, 2026High Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50672519 ↗
• MalfunctionSep 8, 2026Incorrect, Inadequate or Imprecise Result or Readings

  The initial reporter received questionable Glucose HK Gen.3 assay results for two patient samples tested on the cobas c 703 analytical unit.Patient Sample 1:On (b)(6)2026:The initial result was (b)(6).The repeat result was (b)(6).Patient Sample 2:On (b)(6)2026:The initial result from the analyzer was (b)(6). The initial result was deemed clinically incorrect.The repeat result from another c 703 analyzer using a different lot was (b)(6). The repeat result was deemed correct.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50667217 ↗
• MalfunctionSep 3, 2026Incorrect, Inadequate or Imprecise Result or Readings

  The initial reporter received questionable Total Protein Gen.2 assay results for two patient samples tested on the cobas c 703 analytical unit.One patient sample was identified to be reportable for malfunction from the data provided:The initial result was (b)(6).The repeat result was (b)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50583182 ↗
• MalfunctionSep 2, 2026High Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50566086 ↗
• MalfunctionAug 21, 2026Low Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50375233 ↗
• MalfunctionJul 28, 2026High Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50053268 ↗
• MalfunctionJul 2, 2026High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE CREATININE PLUS VER.2 RESULTS FOR 4 PATIENT SAMPLES ON A COBAS C 703 ANALYTICAL UNIT. SAMPLE 1: THE INITIAL RESULT WAS 5.08 MG/DL, AND THE REPEATED RESULT WAS 0.64 MG/DL. SAMPLE 2: ON (B)(6) 2026, THE INITIAL RESULT WAS 5.77 MG/DL, AND THE REPEATED RESULT WAS 0.35 MG/DL. SAMPLE 3 ON (B)(6) 2026, THE INITIAL RESULT WAS 4.68 MG/DL, AND THE REPEATED RESULT WAS 1.18 MG/DL. SAMPLE 4 ON (B)(6) 2026, THE INITIAL RESULT WAS 4.53 MG/DL, AND THE REPEATED RESULT WAS 0.97 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25690822 ↗
• MalfunctionJun 12, 2026Low Test Results

  THE INITIAL REPORTER RECEIVED A QUESTIONABLE CALCIUM GEN.2 (CA2) ASSAY RESULT FOR ONE PATIENT'S SAMPLE TESTED ON THE COBAS C 703 ANALYTICAL UNIT. THE INITIAL RESULT FROM THE ANALYZER WAS 4.97 MG/DL OR 4.5 MG/DL. THE REPEAT RESULTS FROM A COBAS C 702 WERE 9.10 MG/DL AND 9.26 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25487343 ↗
• MalfunctionJun 3, 2026Low Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR TWO PATIENT SAMPLES TESTED WITH ALBUMIN GEN.2 ON A COBAS C 703 ANALYTICAL UNIT. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE FIRST SAMPLE INITIALLY RESULTED IN AN ALBUMIN VALUE OF 2.2 G/L AND IT REPEATED AS 38 G/L. THE SECOND SAMPLE INITIALLY RESULTED IN AN ALBUMIN VALUE OF 2.8 G/L AND IT REPEATED AS 40 G/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25373033 ↗
• MalfunctionJun 1, 2026Mechanical Problem; Device Difficult to Setup or Prepare

  THERE WAS AN ALLEGATION OF QUESTIONABLE PHOSPHATE (INORGANIC) VER.2 AND TOTAL PROTEIN GEN.2 (TP2) ASSAY RESULTS FOR SEVERAL PATIENT SAMPLES TESTED ON A COBAS C 703 ANALYTICAL UNIT. THE FOLLOWING RESULTS WERE PROVIDED AS AN EXAMPLE: SAMPLE 1: THE INITIAL PHOSPHATE RESULT WAS 0.299 MMOL/L (ACCOMPANIED BY A DATA FLAG). THE REPEAT PHOSPHATE RESULT WAS 1.46 MMOL/L. SAMPLE 2: THE INITIAL TP2 RESULT WAS 16.7 G/L. THE REPEAT TP2 RERSULT WAS 70.5 G/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25351647 ↗
• MalfunctionMay 27, 2026Device Difficult to Setup or Prepare

  THE INITIAL REPORTER RECEIVED QUESTIONABLE TOTAL PROTEIN GEN.2 ASSAY RESULTS FOR TWO PATIENT SAMPLES TESTED ON THE COBAS C 703 ANALYTICAL UNIT. ON (B)(6) 2026: PATIENT SAMPLE 1 THE INITIAL RESULT WAS 31.2 G/L. THE REPEAT RESULT WAS 64.8 G/L. THE INITIAL RESULT WAS DEEMED LOW, PROMPTING THE RERUN. THE REPEAT RESULT ALIGNS WITH THE PATIENT'S PREVIOUS RESULTS. THE FIELD SERVICE ENGINEER INSPECTED THE ANALYZER, VERIFIED THE CUVETTE RINSING, ADJUSTED THE ULTRASONIC MIXER (USM), REPLACED THE SAMPLE PROBE, AND PERFORMED A PRECISION CHECK. THE ISSUE WAS NOT RESOLVED, AND NEW QUESTIONABLE RESULTS WERE REPORTED. ON (B)(6) 2026: PATIENT SAMPLE 2 THE INITIAL RESULT WAS 23 G/L. THE REPEAT RESULT WAS 60 G/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25297110 ↗
• MalfunctionMay 12, 2026Low Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE BILT3 BILIRUBIN TOTAL GEN.3 RESULTS FOR 1 PATIENT SAMPLE ON A COBAS C 703 ANALYTICAL UNIT. THE INITIAL RESULT WAS 0.15 MG/DL. ON (B)(6) 2026, THE SAMPLE WAS REPEATED ON ANOTHER MODULE, AND THE RESULT WAS 5.03 MG/DL. THIS RESULT MATCHED THE PATIENT'S CLINICAL PICTURE. THE SAMPLE WAS REPEATED BECAUSE THE INITIAL RESULT DID NOT MATCH THE PATIENT'S CLINICAL PICTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25152712 ↗
• MalfunctionMay 12, 2026Low Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR TWO PATIENT SAMPLES TESTED FOR CHOLESTEROL ON A COBAS C 703 ANALYTICAL UNIT. THE SECOND SAMPLE ALSO HAD DISCREPANT RESULTS FOR GLUCOSE HK GEN.3. THE CUSTOMER REPEATED THE SAMPLES AS THE INITIAL VALUES DID NOT AGREE WITH THE PREVIOUS RESULTS OF THE PATIENTS. THE REPEAT RESULTS WERE DEEMED CORRECT. THE FIRST SAMPLE INITIALLY RESULTED IN A CHOLESTEROL VALUE OF 1.30 MMOL/L AND IT REPEATED AS 5.31 MMOL/L. THE SECOND SAMPLE INITIALLY RESULTED IN A CHOLESTEROL VALUE OF 1.94 MMOL/L AND A GLUCOSE VALUE OF 1.40 MMOL/L. THE SAMPLE WAS REPEATED, RESULTING IN A CHOLESTEROL VALUE OF 5.10 MMOL/L AND A GLUCOSE VALUE OF 4.34 MMOL/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25152711 ↗
• MalfunctionMay 11, 2026Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED FOR LITHIUM ON A COBAS C 703 ANALYTICAL UNIT. THE SAMPLE INITIALLY RESULTED IN A LITHIUM VALUE OF 1.17 MMOL/L AND REPEATED AS 2.04 MMOL/L. THE SAMPLE WAS REPEATED ON A SECOND ANALYZER, RESULTING IN A VALUE OF 1.09 MMOL/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25142689 ↗
• MalfunctionMay 8, 2026Non Reproducible Results

  THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED FOR CREATININE PLUS VER.2 (CREP2) ON A COBAS C 703 ANALYTICAL UNIT. THE INITIAL RESULT WAS 1.50 MG/DL. THE REPEAT RESULT WAS 0.84 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25126569 ↗
• MalfunctionMay 7, 2026Low Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE PHOSPHATE (INORGANIC) VER.2 RESULTS FROM THE COBAS C 703 ANALYTICAL UNIT. THE DOCTOR REQUESTED REPEAT TESTING. SAMPLE 1 INITIAL RESULT WAS 0.27 MMOL/L, AND THE REPEAT RESULT WAS 1.16 MMOL/L. SAMPLE 2 INITIAL RESULT WAS 0.25 MMOL/L, AND THE REPEAT RESULT WAS 1.27 MMOL/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25110389 ↗
• MalfunctionMay 6, 2026Non Reproducible Results

  WE RECEIVED AN ALLEGATION OF A QUESTIONABLE LITHIUM RESULT FOR ONE PATIENT SAMPLE TESTED ON THE COBAS C 703 ANALYTICAL UNIT. THE INITIAL RESULT WAS 0.0182 MMOL/L WITH A DATA FLAG. THE REPEAT RESULT WAS 0.350 MMOL/L. THE REPEAT RESULT WAS 0.0191 MMOL/L WITH A DATA FLAG. THE REPEAT RESULT WAS 0.0147 MMOL/L WITH A DATA FLAG. THE CUSTOMER DEEMED THE FLAGGED RESULTS TO BE THE TRUE RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25092573 ↗
• MalfunctionMay 4, 2026Low Test Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED WITH GLUCOSE HK GEN.3 ASSAY AND 1 PATIENT SAMPLE TESTED WITH PHOSPHATE (INORGANIC) VER.2 ASSAY ON A COBAS C 703 ANALYTICAL UNIT. SAMPLE 1: GLUCOSE: INITIAL RESULT: 139 MG/DL. REPEAT RESULT: 678 MG/DL (TESTED ON A C 503). SAMPLE 2: PHOSPHATE: INITIAL RESULT: 0.356 MMOL/L. REPEAT RESULT: 1.52 MMOL/L (TESTED ON A DIFFERENT C 703). THE WARD PHYSICIAN NOTICED THAT THE INITIAL RESULTS DID NOT MATCH THE PATIENTS' CLINICAL PICTURES, PROMPTING THE REPEAT OF SAMPLE 1 AND SAMPLE 2. THE REPEAT RESULTS WERE CONSISTENT WITH THE PATIENTS' CLINICAL PICTURES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25072626 ↗
• MalfunctionApr 30, 2026Mechanical Problem

  THERE WAS AN ALLEGATION OF DISCREPANT ALBUMIN AND CALCIUM ASSAY RESULTS FOR SEVERAL PATIENT SAMPLES ON A COBAS C 703 ANALYTICAL UNIT. THE FOLLOWING RESULTS WERE PROVIDED FOR EACH ASSAY AS AN EXAMPLE: ALBUMIN: THE INITIAL RESULT WAS 1.17 G/DL. THE REPEAT RESULT WAS 4.51 G/DL. CALCIUM: THE INITIAL RESULT WAS 0.529 MMOL/L. THE REPEAT RESULT WAS 2.28 MMOL/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25049687 ↗
• MalfunctionApr 30, 2026Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE RESULTS FOR QC AND PATIENT SAMPLES FROM THE COBAS C 703 ANALYTICAL UNIT. EXAMPLE 1: THE INITIAL CHOLESTEROL GEN.2 RESULT WAS 44 MG/DL, AND THE REPEAT RESULT WAS 152 MG/DL. EXAMPLE 2: THE INITIAL ALBUMIN GEN.2 RESULT WAS 9 G/L, AND THE REPEAT RESULT WAS 40 G/L. EXAMPLE 3: THE INITIAL ALBUMIN GEN.2 RESULT WAS 8 G/L, AND THE REPEAT RESULT WAS 48 G/L. THE QUESTIONABLE RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25040365 ↗
• MalfunctionApr 29, 2026Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results

  1. DESCRIBE THE EVENT: THERE WAS AN ALLEGATION ABOUT QUESTIONABLE RESULTS FOR 1 PATIENT TESTED FOR TOTAL PROTEIN ASSAY AND 1 PATIENT TESTED FOR PHOSPHORUS ASSAY ON A COBAS C 703 ANALYTICAL UNIT WHEN COMPARED TO A DIFFERENT INSTRUMENT. 2. PATIENT AGE RANGE: ASKU 3. PATIENT WEIGHT RANGE: ASKU 4. PATIENT SEX BREAKDOWN: ASKU 5. PATIENT RACE BREAKDOWN: ASKU. 6. PATIENT ETHNICITY BREAKDOWN: ASKU.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25033515 ↗
• MalfunctionApr 27, 2026Incorrect Measurement

  1. DESCRIBE THE EVENT: THERE WAS AN ALLEGATION OF QUESTIONABLE CREATININE PLUS VER.2 RESULTS FOR 2 PATIENT SAMPLES ON A COBAS C 703 ANALYTICAL UNIT. 2. PATIENT AGE RANGE: ASKU 3. PATIENT WEIGHT RANGE: ASKU 4. PATIENT SEX BREAKDOWN: ASKU 5. PATIENT RACE BREAKDOWN: ASKU 6. PATIENT ETHNICITY BREAKDOWN: ASKU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25000068 ↗
• MalfunctionApr 24, 2026Contamination; Non Reproducible Results

  THE INITIAL REPORTER COMPLAINED OF A DISCREPANT LOW RESULT FOR 1 PATIENT SAMPLE TESTED FOR CALCIUM GEN.2 (CA2) ON A COBAS C 703 ANALYTICAL UNIT. THE INITIAL RESULT WAS 5.04 MG/DL. THE REPEAT RESULT WAS 8.87 MG/DL. THE SAMPLE WAS REPEATED AGAIN WITH A RESULT OF 8.80 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24987407 ↗
• MalfunctionApr 24, 2026Incorrect, Inadequate or Imprecise Result or Readings; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE RESULTS FROM THE COBAS C 703 ANALYTICAL UNIT. DATA FOR ONE SAMPLE TESTED FOR RHEUMATOID FACTORS II WAS PROVIDED. THE INITIAL RESULT WAS 16.9 IU/ML. THE REPEAT RESULTS WERE 27.5 IU/ML, 13.3 IU/ML, AND 14 IU/ML. THE QUESTIONABLE RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24980021 ↗