Calcium Gen.2 08057427190Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 07613336121092), received between Apr 27, 2023 and Sep 30, 2026 — classified as 21 malfunctions.

The most frequently reported specific device problem is “Non Reproducible Results” (12 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 16, 2026.

Most reported problems

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Non Reproducible Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50949996 ↗
• MalfunctionSep 10, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50717074 ↗
• MalfunctionSep 2, 2026Non Reproducible Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50566391 ↗
• MalfunctionMar 19, 2026Low Test Results; 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 503 ANALYTICAL UNIT. THE INITIAL RESULT WAS 2.4 MG/DL. THE TECHNICIAN QUESTIONED THIS RESULT. THE SAMPLE WAS REPEATED ON A DIFFERENT C503 ANALYZER WITH A RESULT OF 8.86 MG/DL. THIS RESULT WAS BELIEVED TO BE CORRECT. THE QUESTIONABLE RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24637006 ↗
• MalfunctionMar 2, 2026Non Reproducible Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED WITH CALCIUM GEN.2 ASSAY ON A COBAS PURE C 303 ANALYTICAL UNIT. THE INITIAL RESULT WAS 7.10 MG/DL. THE PHYSICIAN QUESTIONED THE INITIAL RESULT. ON (B)(6) 2026, THE REPEAT RESULT AFTER RECALIBRATION OF THE ASSAY WAS 10.2 MG/DL. THE REPEAT RESULT WAS DEEMED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24485075 ↗
• MalfunctionDec 1, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THERE WAS AN ALLEGATION OF QUESTIONABLE RESULTS FROM THE COBAS C 503 ANALYTICAL UNIT. THE CUSTOMER ALLEGED THERE WAS INTERFERENCE FROM THE PATIENT'S MEDICATIONS. THIS MEDWATCH IS FOR THE CALCIUM GEN.2 ASSAY. REFER TO THE MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR THE MAGNESIUM GEN.2 ASSAY. PATIENT 1: THE INITIAL MAGNESIUM GEN.2 RESULT WAS 0.149 MG/DL, AND THE INITIAL CALCIUM GEN.2 RESULT WAS - 0.101 MG/DL. THIS PATIENT WAS BEING TREATED WITH ISOPRINOSINE. THE SAMPLE WAS REPEATED USING A COBAS C501, AND THE MAGNESIUM RESULT WAS 0.544 MG/DL. THE CALCIUM RESULT WAS -0.0693 MG/DL. PATIENT 2: THE INITIAL MAGNESIUM RESULT WAS 0.218 MG/DL, AND THE INITIAL CALCIUM WAS 1.18 MG/DL. THIS PATIENT WAS BEING TREATED WITH CORTIZON. THE SAMPLE WAS REPEATED USING A COBAS C501, AND THE MAGNESIUM RESULT WAS 0.214 MG/DL. THE QUESTIONABLE RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23679878 ↗
• MalfunctionJun 25, 2025High Test Results; High Test Results

  THE INITIAL REPORTER COMPLAINED OF A DISCREPANT HIGH RESULT FOR 1 PATIENT SAMPLE TESTED FOR CALCIUM GEN.2 (CA2) ON A COBAS C 303 ANALYTICAL UNIT. THE INITIAL RESULT WAS 11.2 MG/DL. THE REPEAT RESULT WAS 7.22 MG/DL. ON 02-JUN-2025, THE RESULT WAS 7.76 MG/DL. THE QUESTIONABLE RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THE LOWER RESULTS WERE BELIEVED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22326947 ↗
• MalfunctionJan 17, 2025High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT PLASMA SAMPLE TESTED WITH CALCIUM GEN.2 (CA2) ASSAY ON A COBAS C503 ANALYTICAL UNIT WHEN COMPARED TO A DIFFERENT COBAS C503 ANALYTICAL UNIT. INITIAL RESULT: 3.12 MMOL/L. 1ST REPEAT RESULT: 2.54 MMOL/L (TESTED WITH AUTOMATIC RERUN). 2ND REPEAT RESULT: 2.56 MMOL/L (TESTED ON ANOTHER C503). NO QUESTIONABLE RESULT WAS REPORTED OUTSIDE THE LABORATORY. THE REPEAT RESULTS WERE DEEMED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21180742 ↗
• MalfunctionNov 14, 2024Non Reproducible Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE CALCIUM GEN.2 RESULTS FROM THE COBAS C 503 ANALYTICAL UNIT. THE INITIAL RESULT WAS 1.92 MMOL/L. THE REPEAT RESULTS WERE 2.34 MMOL/L AND 2.33 MMOL/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20689478 ↗
• MalfunctionNov 4, 2024Non Reproducible Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE CA2 CALCIUM GEN.2 RESULTS FOR 1 PATIENT SAMPLE ON A COBAS C 503 ANALYTICAL UNIT. THE INITIAL RESULT WAS 1.57 MG/DL. THE RESULT WAS QUESTIONED WHICH PROMPTED THE CUSTOMER TO REPEAT THE SAMPLE. THE SAMPLE WAS REPEATED ON ANOTHER ANALYZER AND THE RESULT WAS 2.19 MG/DL. A NEW PATIENT SAMPLE WAS COLLECTED AND THE CALCIUM RESULT WAS 2.26 MG/DL, WHICH CONFIRMED THE REPEAT RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20603176 ↗
• MalfunctionJun 11, 2024Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR TWO PATIENT SAMPLES TESTED ON A COBAS C 303 ANALYTICAL UNIT. SAMPLE 1 HAD DISCREPANT RESULTS WHEN TESTED WITH THE NA ELECTRODE AND CL ELECTRODE. REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE NA ELECTRODE AND REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE CL ELECTRODE. SAMPLE 1 ALSO HAD DISCREPANT RESULTS WHEN TESTED WITH THE ELECSYS TROPONIN T GEN 5 ON A COBAS PURE E 402 ANALYTICAL UNIT. REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE TROPONIN T ASSAY. SAMPLE 2 HAD DISCREPANT RESULTS WHEN TESTED WITH THE NA ELECTRODE, K ELECTRODE, CL ELECTRODE, AND CALCIUM GEN.2. THIS MEDWATCH WILL APPLY TO THE NA ELECTRODE. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE NA ELECTRODE. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE K ELECTRODE. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE CL ELECTRODE. A PHYSICIAN QUESTIONED THE INITIAL SAMPLE VALUES SO THE SAMPLES WERE R

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19514943 ↗
• MalfunctionMay 29, 2024Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE CALCIUM GEN.2 (CA2) RESULTS FROM MULTIPLE PATIENT SAMPLES TESTED ON THE COBAS C 503 ANALYTICAL UNIT. THE CUSTOMER STATED THAT THEIR WATER SYSTEM WAS SERVICED ON 01-MAY-2024 AND THAT THEY STARTED RECEIVING LOW CALCIUM RESULTS FROM THE ANALYZER ON 03-MAY-2024. THE REPORTER WAS ABLE TO PROVIDE TWO EXAMPLES OF DISCREPANT RESULTS: THE INITIAL RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE DELTA CHECK FLAG IN THE MIDDLEWARE PROMPTED THE RERUN OF THE PATIENT SAMPLES. SAMPLE (B)(6). THE INITIAL RESULT WAS 8.4 MG/DL WITH A DATA FLAG. THE REPEAT RESULT WAS 10.1 MG/DL. SAMPLE (B)(6) THE INITIAL RESULT WAS 6.9 MG/DL WITH A DATA FLAG. THE REPEAT RESULT WAS 8.7 MG/DL. THE REPEAT RESULTS WERE DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19415081 ↗
• MalfunctionApr 16, 2024Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Incorrect, Inadequate or Imprecise Result or Readings; High Test Results

  THE INITIAL REPORTER RECEIVED A QUESTIONABLE CALCIUM GEN.2 (CA2) RESULT FROM MULTIPLE PATIENT SAMPLES TESTED ON THE COBAS C 303 ANALYTICAL UNIT - EMC. THE REPORTER WAS ABLE TO PROVIDE TWO EXAMPLES OF DISCREPANT RESULTS: THE INITIAL RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY AS HIGH RESULTS WERE OBSERVED IN THE LINE PROMPTING THE RERUN OF THE PATIENT SAMPLES. SAMPLE (B)(6) THE INITIAL RESULT WAS 12.5 MG/DL. THE REPEAT RESULT WAS 9.5 MG/DL. SAMPLE (B)(6) THE INITIAL RESULT WAS 12.4 OR 12.5 MG/DL. THE REPEAT RESULT WAS 9.6 MG/DL. THE REPEAT RESULTS WERE DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19114870 ↗
• MalfunctionApr 15, 2024High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE CALCIUM GEN.2 RESULTS FOR 2 PATIENTS ON A COBAS C 503 ANALYTICAL UNIT. PATIENT 1: THE INITIAL RESULT WAS 2.65 MMOL/L. THE SAMPLE WAS REPEATED AND THE RESULT HAD AN INVALIDATING FLAG. THE SAMPLE WAS REPEATED (AFTER CENTRIFUGATION) AGAIN ON ANOTHER ANALYZER AND THE RESULT HAD AN INVALIDATING FLAG. THE SAMPLE WAS REPEATED (AFTER CENTRIFUGATION) ON THE INITIAL ANALYZER AND THE RESULT WAS 1.91 MMOL/L. THE SAMPLE WAS REPEATED (AFTER CENTRIFUGATION) ON ANOTHER ANALYZER AND THE RESULT WAS 1.96 MMOL/L. PATIENT 2: ON (B)(6) 2024 THE INITIAL RESULT WAS 2.94 MMOL/L. THE SAMPLE WAS REPEATED AND THE RESULT HAD AN INVALIDATING FLAG SO THE SAMPLE WAS REPEATED AGAIN (AFTER A NEW CENTRIFUGATION) AND THE RESULT WAS 2.52 MMOL/L. THE SAMPLES WERE REPEATED DUE TO THE LABORATORY'S RULE TO REPEAT SAMPLES WITH RESULTS THAT ARE >2.55 MMOL/L WITHOUT THE PATIENT HAVING PRIOR RESULTS <48 HOURS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19106665 ↗
• MalfunctionFeb 12, 2024Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE CALCIUM GEN.2 (CA2) RESULTS FROM TWO PATIENT SAMPLES TESTED ON THE COBAS PRO C 503 ANALYTICAL UNIT. THE INITIAL RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. SAMPLE ID: (B)(6).THE PATIENT SAMPLE WAS RERUN ACCORDING TO THE PHYSICIAN'S REQUEST. THE INITIAL RESULT WAS 3.1 MG/DL. THE REPEAT RESULT WAS 7.24 MG/DL. THIS RESULT WAS DEEMED CORRECT. SAMPLE ID: (B)(6). THE PATIENT SAMPLE WAS RERUN BECAUSE THE INITIAL RESULT WAS DEEMED LOW. THE INITIAL RESULT WAS 5.73 MG/DL. THE FIRST REPEAT RESULT WAS 7.64 MG/DL. THIS RESULT WAS DEEMED CORRECT. THE SECOND REPEAT RESULT WAS 8.38 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18686025 ↗
• MalfunctionJan 19, 2024Incorrect, Inadequate or Imprecise Result or Readings; Optical Problem; Incorrect, Inadequate or Imprecise Result or Readings; Optical Problem

  THE INITIAL REPORTER RECEIVED A QUESTIONABLE CALCIUM GEN.2 (CA2) RESULT FROM ONE PATIENT SAMPLE TESTED ON THE COBAS PURE C 303 ANALYTICAL UNIT. THE INITIAL RESULT OF THE INITIAL PATIENT SAMPLE FROM THE ANALYZER WAS 6.8 MG/DL. THE FIRST REPEAT RESULT OF THE INITIAL PATIENT SAMPLE FROM THE ANALYZER WAS 9.5 MG/DL. THE SECOND REPEAT RESULT OF THE INITIAL PATIENT SAMPLE FROM THE C 501 MODULE WAS 9.5 MG/DL. THE RESULT OF A NEW PATIENT SAMPLE WAS 9.5 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18545851 ↗
• MalfunctionAug 7, 2023Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Incorrect, Inadequate or Imprecise Result or Readings; High Test Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT'S PLASMA SAMPLE TESTED WITH CALCIUM (CA2) ASSAY ON A COBAS PRO C503 ANALYTICAL UNIT WHEN COMPARED TO A DIFFERENT COBAS PRO C503 ANALYTICAL UNIT. INITIAL RESULT: 8.75 MG/DL (C503 UNIT IN QUESTION) AUTOMATIC REPEAT RESULT: 10.7 MG/DL (C503 UNIT IN QUESTION) MANUAL REPEAT RESULT: 9.01 MG/DL (TESTED ON A DIFFERENT C503 UNIT) THE MANUAL REPEAT RESULT WAS DEEMED TO BE CORRECT AS IT MATCHED THE PATIENT'S PREVIOUS CA2 RESULT OF 9.1 MG/DL (TESTED 48 HOURS BEFORE THE EVENT). REPORTEDLY A CORRECTED REPORT WAS ISSUED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17475392 ↗
• MalfunctionJul 6, 2023Low Test Results; Low Test Results

  THE INITIAL REPORTER QUESTIONED LOW RESULTS FOR MULTIPLE PATIENT SAMPLES TESTED FOR CALCIUM GEN.2 (CA2) ON A COBAS PRO C 503 ANALYTICAL UNIT. THE INITIAL RESULT WAS 6.3 MG/DL. THE REPEAT RESULT FROM A DIFFERENT C503 ANALYZER WAS 9.2 MG/DL. THE REPEAT RESULT WAS BELIEVED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17270052 ↗
• MalfunctionMay 30, 2023Unable to Obtain Readings; Unable to Obtain Readings

  THE INITIAL REPORTER QUESTIONED THE RESULTS OF 1 PEDIATRIC PATIENT SAMPLE TESTED FOR CALCIUM GEN.2 (CA2) ON A COBAS PRO C 503 ANALYTICAL UNIT. THE INITIAL RESULT FROM A MICRO CUP WAS 2.75 MMOL/L. THE SAMPLE WAS REPEATED 3 TIMES AND A DATA FLAG WAS RECEIVED WITH NO NUMERIC RESULT. THE SAMPLE WAS REPEATED AGAIN WITH A RESULT OF 2.29 MMOL/L. ON (B)(6) 2023 THE SAMPLE WAS REPEATED WITH NO NEW CENTRIFUGATION PERFORMED AND THE RESULT WAS 2.36 MMOL/L. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE C503 ANALYZER SERIAL NUMBER WAS (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17021824 ↗
• MalfunctionMay 1, 2023Non Reproducible Results; Non Reproducible Results

  WE RECEIVED AN ALLEGATION OF A DISCREPANT LOW RESULT FOR 1 PATIENT'S SAMPLE TESTED WITH CALCIUM (CA2) ASSAY ON A COBAS C303 ANALYTICAL UNIT SERIAL NUMBER (B)(6). INITIAL RESULT: 5.36 MG/DL. 1ST RERUN RESULT: 10.3 MG/DL. 2ND RERUN RESULT: 10.4 MG/DL. THE QUESTIONABLE RESULT WAS REPORTED OUTSIDE THE LABORATORY. THE PHYSICIAN QUESTIONED THE RESULT AND REQUESTED A RERUN. THE SAMPLE WAS HEPARINIZED PLASMA IN HITACHI CUPS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16846152 ↗
• MalfunctionApr 27, 2023Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE CALCIUM (CA2) ASSAY RESULTS FROM FIVE PATIENT SAMPLES TESTED ON THE COBAS PRO C 503 ANALYTICAL UNIT WITH SERIAL NUMBER (B)(6). IT WAS ASKED, BUT IT IS NOT KNOWN IF THE INITIAL RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. ON (B)(6) 2023: SAMPLE 1 THE INITIAL RESULT FROM LINE 1 WAS 3.02 MMOL/L. THE REPEAT RESULT FROM LINE 2 WAS 1.94 MMOL/L. ON (B)(6) 2023: SAMPLE 942831986S0 - THE INITIAL RESULT FROM LINE 1 WAS 2.64 MMOL/L. THE FIRST REPEAT RESULT FROM LINE 1 WAS 2.37 MMOL/L. THE SECOND REPEAT RESULT FROM LINE 2 WAS 2.19 MMOL/L. SAMPLE 942831984S0 - THE INITIAL RESULT FROM LINE 1 WAS 2.77 MMOL/L. THE REPEAT RESULT FROM LINE 2 WAS 2.28 MMOL/L. SAMPLE 942813982S0 -THE INITIAL RESULT FROM LINE 1 WAS 2.68 MMOL/L. THE REPEAT RESULT FROM LINE 2 WAS 2.18 MMOL/L. SAMPLE 942831983S0 - THE INITIAL RESULT FROM LINE 1 WAS 2.74 MMOL/L. THE REPEAT RESULT FROM LINE 2 WAS 2.26 MMOL/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16825720 ↗