Calcium Gen2 5168449190Recalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 04015630924936), received between Jul 17, 2018 and Mar 30, 2026 — classified as 34 malfunctions.

The most frequently reported specific device problem is “Non Reproducible Results” (16 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 25 most recent of 34 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 30, 2026Non Reproducible Results

  THERE WAS AN ALLEGATION OF A QUESTIONABLE CALCIUM GEN.2 RESULT FROM THE COBAS 8000 C702 MODULE FOR TWO PATIENT SAMPLES. PATIENT 1 HAD A HIGH RESULT OF 9.90 MG/DL, AND LOW RESULT OF 7.4 MG/DL. ON (B)(6) 2026, PATIENT 2 HAD A HIGH RESULT OF 10.1 MG/DL AND A LOW RESULT OF 7.8 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24716125 ↗
• MalfunctionDec 11, 2025High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH CALCIUM GEN.2 ON A COBAS 8000 C702 MODULE. THE SAMPLE INITIALLY RESULTED IN A CALCIUM VALUE OF 12.9 MG/DL. THE CUSTOMER REPEATED THE SAMPLE DUE TO A FAILED LABORATORY DELTA CHECK. THE SAMPLE WAS REPEATED ON ANOTHER ANALYZER, RESULTING IN A CALCIUM VALUE OF 9.6 MG/DL. THE REPEAT VALUE WAS DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23780711 ↗
• MalfunctionSep 3, 2025Non Reproducible Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE CALCIUM GEN.2 RESULTS FOR 1 PATIENT SAMPLE ON A COBAS 8000 C702 MODULE. THE INITIAL CALCIUM RESULT WAS 11.46 MG/DL. THE SAMPLE WAS REPEATED AND THE RESULT WAS 9.32 MG/DL. THE SAMPLE WAS ALSO REPEATED TWICE ON ANOTHER C702 ANALYZER AND THE RESULTS WERE 9.72 MG/DL AND 9.74 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22953044 ↗
• MalfunctionJul 30, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THERE WAS AN ALLEGATION OF QUESTIONABLE CALCIUM RESULTS FROM THE COBAS 8000 C702 MODULE. EXAMPLE 1 INITIAL RESULT WAS 1.5 AND THE REPEAT RESULT WAS 2.14. EXAMPLE 2 INITIAL RESULT WAS 1.55 AND THE REPEAT RESULT WAS 2.23. EXAMPLE 3 INITIAL RESULT WAS 1.48 AND THE REPEAT RESULT WAS 2.17. EXAMPLE 4 INITIAL RESULT WAS 1.88 AND THE REPEAT RESULT WAS 2.3. ON (B)(6) 2025: EXAMPLE 5 INITIAL RESULT WAS 0.75 AND THE REPEAT RESULT WAS 1.54. EXAMPLE 6 INITIAL RESULT WAS 1.63 AND THE REPEAT RESULT WAS 2.0. EXAMPLE 7 INITIAL RESULT WAS 1.69 AND THE REPEAT RESULT WAS 2.3. THE UNIT OF MEASURE WAS NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22663232 ↗
• MalfunctionMay 19, 2025False Positive Result; False Positive Result

  THERE WAS AN ALLEGATION OF QUESTIONABLE CALCIUM GEN.2 RESULTS FROM THE COBAS 8000 COBAS C 701 MODULE. THE INITIAL RESULT WAS 14.3 MG/DL AND DID NOT MATCH THE PATIENT¿S CONDITION. THE REPEAT RESULT WAS 8.2 MG/DL. THE QUESTIONABLE RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22043105 ↗
• MalfunctionJan 31, 2025High Test Results; High Readings; Non Reproducible Results; High Test Results; High Readings; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE CALCIUM GEN. 2 RESULTS FOR 19 PATIENT SAMPLES ON A COBAS 8000 C 702 MODULE. EXAMPLES FOR 3 OF THE ALLEGED PATIENT SAMPLES: PATIENT 1: THE INITIAL RESULT WAS 3.38 MMOL/L AND THE REPEATED RESULT WAS 2.47 MMOL/L. PATIENT 2: THE INITIAL RESULT WAS 3.23 MMOL/L AND THE REPEATED RESULT WAS 2.32 MMOL/L. PATIENT 3: THE INITIAL RESULT WAS 3.14 MMOL/L AND THE REPEATED RESULT WAS 2.26 MMOL/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21286931 ↗
• MalfunctionSep 13, 2024Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Optical Problem; Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Optical Problem

  THE INITIAL REPORTER RECEIVED QUESTIONABLE CA2 CALCIUM GEN.2 RESULTS FROM 567 PATIENT SAMPLES TESTED ON THE COBAS 8000 C702 MODULE. THE REPORTER STATED THAT THEY NOTED THE VARIATION IN QC AND PATIENT RESULTS WHEN THEY STARTED USING THE REPORTED REAGENT LOT. THE REPORTER WAS ABLE TO PROVIDE ONE PATIENT SAMPLE WITH DISCREPANT RESULTS: THE INITIAL RESULT WAS 9.6 MG/DL. THE REPEAT RESULT WAS 7.7 MG/DL. THE INITIAL RESULT WAS NOT REPORTED OUTSIDE THE LABORATORY AS IT WAS DEEMED INCORRECT. THE REPEAT RESULT WAS DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20214895 ↗
• MalfunctionJul 17, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THERE WAS AN ALLEGATION OF DISCREPANT RESULTS FOR 13 PATIENT SAMPLES TESTED FOR CALCIUM GEN. 2 (CA2) ON A COBAS 8000 C 702 MODULE BETWEEN (B)(6) 2024. REFER TO THE ATTACHED DATA FOR THE PATIENT RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19763731 ↗
• MalfunctionJun 11, 2024Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results; Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results

  THE INITIAL REPORTER RECEIVED A QUESTIONABLE CA2 CALCIUM GEN.2 RESULT FROM AN UNSPECIFIED NUMBER OF PATIENT SAMPLES TESTED ON THE COBAS 8000 C702 MODULE. THE REPORTER WAS ABLE TO PROVIDE TWO PATIENT SAMPLES WITH DISCREPANT RESULTS: THE INITIAL RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE INITIAL RESULTS WERE FLAGGED AS CRITICALLY LOW IN THE LABORATORY INFORMATION SYSTEM (LIS) PROMPTING THE RERUN OF THE PATIENT SAMPLES IN THEIR OTHER C 702 MODULE. SAMPLE (B)(6) THE INITIAL RESULT FROM THE MODULE WAS 3.1 MG/DL. THE REPEAT RESULT FROM THE OTHER MODULE WAS 6.6 MG/DL. SAMPLE (B)(6) THE INITIAL RESULT FROM THE MODULE WAS 4.1 MG/DL. THE REPEAT RESULT FROM THE OTHER MODULE WAS 7.3 MG/DL. THE REPEAT RESULTS WERE DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19512264 ↗
• MalfunctionJun 3, 2024High Test Results; High Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH CALCIUM GEN. 2 ON A COBAS 8000 C702 MODULE. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.THE SAMPLE INITIALLY RESULTED IN A CALCIUM VALUE OF 6.8 MG/DL. SINCE THE VALUE WAS CRITICAL, THE SAMPLE WAS REPEATED.THE REPEAT CALCIUM RESULT WAS 9.3 MG/DL AND THIS VALUE WAS DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19453850 ↗
• MalfunctionMar 26, 2024Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results; Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results

  THERE WAS AN ALLEGATION OF A QUESTIONABLE CALCIUM GEN.2 RESULT FOR ONE PATIENT SAMPLE FROM THE COBAS 8000 C702 MODULE. THE INITIAL RESULT WAS 1.84 MMOL/L. AS THE RESULT DID NOT FIT THE PATIENT HISTORY OR ACCOMPANYING PO4 AND VITAMIN D RESULTS, THE SAMPLE WAS REPEATED WITH A RESULT OF 2.44 MMOL/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18978533 ↗
• MalfunctionMar 15, 2024Low Test Results; Low Test Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT SERUM SAMPLE TESTED WITH CALCIUM GEN.2 (CA2) ASSAY ON A COBAS 8000 COBAS C701 ANALYZER. INITIAL RESULT: 0.01 MMOL/L. 1ST REPEAT RESULT: 0.04 MMOL/L. ON (B)(6) 2024 THE SAMPLE WAS REPEATED FOR THE 2ND TIME. 2ND REPEAT RESULT: -0.02 MMOL/L. THE CUSTOMER QUESTIONED THE RESULTS AS THEY LOOKED VERY LOW/UNBELIEVABLE, AND THEREFORE, NO QUESTIONABLE RESULT WAS REPORTED OUTSIDE THE LABORATORY. THE CUSTOMER STATED THAT THE RESULTS WERE NOT ACCOMPANIED BY DATA FLAGS ALTHOUGH THEY WERE OBTAINED BELOW THE MEASURING RANGE (0.2 MMOL/L).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18915029 ↗
• MalfunctionMar 11, 2024Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR AN UNSPECIFIED NUMBER OF PATIENT SAMPLES TESTED WITH CA2 (CALCIUM) ON TWO COBAS 8000 701 MODULE ANALYZERS. SOME RESULTS WERE FOUND TO BE TOO LOW AND OTHERS WERE TOO HIGH. THE CUSTOMER NOTED THAT DOCTORS HAVE BEEN COMPLAINING THAT CALCIUM VALUES ARE TOO HIGH. AN EXAMPLE WAS PROVIDED FOR ONE PATIENT SAMPLE WITH DISCREPANT CALCIUM RESULTS. THE SAMPLE INITIALLY RESULTED IN A CALCIUM VALUE OF 3 MG/DL WHEN TESTED ON A FIRST C701 ANALYZER. THE SAMPLE WAS REPEATED ON THE SECOND C701 ANALYZER, RESULTING IN A CALCIUM VALUE OF 8 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18874863 ↗
• MalfunctionFeb 23, 2024Low Test Results; Low Test Results

  THE INITIAL REPORTER QUESTIONED LOW RESULTS FOR MULTIPLE PATIENT SAMPLES TESTED FOR CA2 ON A COBAS 8000 C 701 MODULE. THE CUSTOMER STATED THAT CORRECTED REPORTS WERE ISSUED. THE CUSTOMER PROVIDED AN EXAMPLE OF THE TYPE OF RESULTS THAT WERE RECEIVED. THE INITIAL RESULTS WOULD BE < 8 MG/DL. THE REPEAT RESULTS WOULD BE "AS HIGH AS" 10.2 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18768044 ↗
• MalfunctionJan 10, 2024Mechanical Problem; Low Test Results; Mechanical Problem; Low Test Results

  THE INITIAL REPORTER QUESTIONED LOW RESULTS FOR MULTIPLE PATIENT SAMPLES TESTED FOR CALCIUM (CA) ON A COBAS 8000 C 702 MODULE. THE CUSTOMER REPEATED PATIENT SAMPLES AND DISCREPANT RESULTS WERE IDENTIFIED FOR 3 PATIENT SAMPLES. PATIENT 1 INITIAL RESULT WAS 7.0 MG/DL. THE REPEAT RESULT WAS 9.3 MG/DL. "PATIENT 3" INITIAL RESULT WAS 6.4 MG/DL. THE REPEAT RESULT WAS 8.6 MG/DL. "PATIENT 4" INITIAL RESULT WAS 6.2 MG/DL. THE REPEAT RESULT WAS 8.6 MG/DL. THE REPEAT RESULTS WERE BELIEVED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18483125 ↗
• MalfunctionNov 17, 2023High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF A QUESTIONABLE CALCIUM GEN.2 RESULT FROM THE COBAS 8000 C702 MODULE. THE INITIAL RESULT WAS 3.15 MMOL/L AND WAS REPORTED OUTSIDE OF THE LABORATORY. THE CLINICIAN FELT IT WAS NOT CONSISTENT WITH THE PATIENT'S CLINICAL MANIFESTATIONS AND REQUESTED REPEAT TESTING. THE REPEAT RESULT ON THE SAME ANALYZER WAS 2.41 MMOL/L. THE REPEAT RESULT ON ANOTHER COBAS C702 ANALYZER WAS 2.47 MMOL/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18159347 ↗
• MalfunctionOct 30, 2023Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED FOR CALCIUM (CA2) ON A COBAS 8000 C 702 MODULE. THE INITIAL RESULT WAS 1.45 MMOL/L. THE REPEAT RESULT WAS 2.25 MMOL/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18031065 ↗
• MalfunctionSep 19, 2023Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER RECEIVED A QUESTIONABLE CA2 CALCIUM GEN.2 RESULT FROM ONE PATIENT SAMPLE TESTED ON THE COBAS 8000 C702 MODULE. THE DOCTOR QUESTIONED THE RESULT PROMPTING THE RERUN OF THE PATIENT SAMPLE. A NEW SAMPLE WAS ALSO COLLECTED FROM THE PATIENT. THE INITIAL RESULT OF THE INITIAL SAMPLE WAS 2.86 MMOL/L. THE REPEAT RESULT OF THE INITIAL SAMPLE WAS 2.18 MMOL/L. THIS RESULT WAS DEEMED CORRECT. THE RESULT OF THE NEW SAMPLE WAS 2.24 MMOL/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17772175 ↗
• MalfunctionSep 8, 2023Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results; Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE CA2 CALCIUM GEN.2 RESULTS FROM TWO PATIENT SAMPLES TESTED ON THE COBAS 8000 COBAS C 701 MODULE. THE INITIAL RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY AS THEY WERE DEEMED TOO LOW, PROMPTING THE RERUN OF THE PATIENT SAMPLES. SAMPLE ID (B)(6): ON (B)(6) 2023, THE INITIAL RESULT FROM THE MODULE WAS 5.0 MG/DL. THE REPEAT RESULT FROM THE MODULE WAS 9.0 MG/DL. THIS RESULT WAS DEEMED CORRECT. SAMPLE ID (B)(6): THE PATIENT SAMPLE WAS ALSO RERUN ON ANOTHER MODULE. ON (B)(6) 2023, THE INITIAL RESULT FROM THE MODULE WAS 7.2 MG/DL. THE FIRST REPEAT RESULT FROM THE MODULE UPON AUTO-REPEAT WAS 6.0 MG/DL. THE SECOND REPEAT RESULT FROM THE OTHER MODULE WAS 8.2 MG/DL. THIS RESULT WAS DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17709828 ↗
• MalfunctionAug 4, 2023Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results; Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE CA2 CALCIUM GEN.2 RESULTS FOR 4 PATIENT SAMPLES ON A COBAS 8000 C 702 MODULE. THE CUSTOMER WAS PROMPTED TO REPEAT THE SAMPLES AS THE RESULTS WERE LOW. FOR PATIENT 1, THE INITIAL CA2 RESULT WAS 6.4 MG/DL. THE REPEAT RESULT FROM ANOTHER ANALYZER WAS 8.8 MG/DL. FOR PATIENT 2, THE INITIAL CA2 RESULT WAS 4.9 MG/DL. THE REPEAT RESULT FROM ANOTHER ANALYZER WAS 9.2 MG/DL. FOR PATIENT 3, THE INITIAL CA2 RESULT WAS 5.2 MG/DL. THE REPEAT RESULT FROM ANOTHER ANALYZER WAS 7.8 MG/DL. FOR PATIENT 4, THE INITIAL CA2 RESULT WAS 7.7 MG/DL. THE REPEAT RESULT FROM ANOTHER ANALYZER WAS 9.3 MG/DL. THE REPEAT RESULTS WERE DEEMED CORRECT. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17465473 ↗
• MalfunctionJun 21, 2023Low Test Results; Low Test Results

  WE RECEIVED AN ALLEGATION OF DISCREPANT LOW RESULTS FOR 2 PATIENTS' SAMPLES TESTED WITH CALCIUM GEN.2 (CA2) ASSAY ON A COBAS 8000 C702 MODULE WHEN COMPARED TO A DIFFERENT COBAS 8000 C702 MODULE. SAMPLE 1: INITIAL RESULT: 5.4 MG/DL. REPEAT RESULT: 9.2 MG/DL. SAMPLE 2: INITIAL RESULT: 4.3 MG/DL. REPEAT RESULT: 9.1 MG/DL. BOTH INITIAL RESULTS WERE RECOGNIZED AS CRITICAL RESULTS AS THEY WERE SHOWN TO BE BELOW THE NORMAL RANGE. REPORTEDLY A CORRECTED REPORT WAS ISSUED FOR SAMPLE 1.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17172944 ↗
• MalfunctionMay 30, 2023Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE CA2 CALCIUM GEN.2 RESULTS FROM AN UNSPECIFIED NUMBER OF PATIENT SAMPLES TESTED ON THE COBAS 8000 COBAS C 701 MODULE. THE INITIAL RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THE REPORTER DID NOT BELIEVE THE INITIAL ELEVATED RESULTS WHICH PROMPTED THE RERUN OF THE PATIENT SAMPLES. THE REPORTER WAS NOT ABLE TO PROVIDE SPECIFIC RESULTS BUT STATED THAT THE DIFFERENCES IN THE RESULTS WERE AS HIGH AS 5 TO 6 MG/DL AT RESULTS GREATER THAN 15 MG/DL. THE LOWER RESULT WAS DEEMED CORRECT. THE REAGENT LOT NUMBER IS 694033. THE EXPIRATION DATE WAS REQUESTED BUT NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17020813 ↗
• MalfunctionMay 18, 2023Low Test Results; Low Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE CALCIUM GEN.2 RESULT FROM THE COBAS 8000 COBAS C 701 MODULE. SAMPLE 1 ORIGINAL RESULT WAS 5.2 MG/DL AND THE REPEAT RESULT WAS 9.4 MG/DL. SAMPLE 2 ORIGINAL RESULT WAS 5.6 MG/DL AND THE REPEAT RESULT WAS 9.7 MG/DL. SAMPLE 3 ORIGINAL RESULT WAS 5.9 MG/DL AND THE REPEAT RESULT WAS 8.5 MG/DL. THE QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE REPEAT RESULTS WERE BELIEVED CORRECT. THE REGENT LOT NUMBER WAS 693360. THE EXPIRATION DATE WAS REQUESTED BUT WAS NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16954428 ↗
• MalfunctionMar 31, 2023Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR TWO PATIENT SAMPLES TESTED WITH CA2 CALCIUM GEN.2 ON A COBAS 8000 C 702 MODULE (SERIAL NUMBER (B)(4)). NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE FIRST SAMPLE INITIALLY RESULTED IN A CALCIUM VALUE OF 6.15 MG/DL AND IT REPEATED AS 9.39 MG/DL. THE SECOND SAMPLE INITIALLY RESULTED IN A CALCIUM VALUE OF 6.29 MG/DL AND IT REPEATED AS 9.37 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16657683 ↗
• MalfunctionMar 15, 2023Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  WE RECEIVED AN ALLEGATION OF QUESTIONABLE RESULTS FOR 1 PATIENT SAMPLE TESTED WITH CALCIUM GEN.2 (CA2) ASSAY ON A COBAS 8000 C701 MODULE SERIAL NUMBER (B)(4). ON (B)(6) 2023 THE CUSTOMER RAN THE SAMPLE AND IT RESULTED IN AN INITIAL CALCIUM VALUE OF 6.71MG/DL. THE LIS FLAGGED THE RESULT AS CRITICAL WHICH PROMPTED THE RERUN OF THE RESULTS. ON (B)(6) 2013 THE CUSTOMER REPEATED THE TEST AND THE CALCIUM RESULT WAS 9.17MG/DL. THE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE REPEAT RESULTS DEEMED TO BE THE CORRECT RESULTS. THE LAST CALIBRATION PERFORMED WAS ON 6-FEB 2023 AND WAS ACCEPTABLE. THE LABORATORY PERFORMED QC ON THE DAYS OF THE TESTING AND THEY ALL PASSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16549144 ↗