Calcium Gen2 5061482190Recalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 04015630924035), received between Jul 27, 2018 and Dec 22, 2025 — classified as 36 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (20 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 36 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 22, 2025High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE CALCIUM GEN.2 RESULTS FOR 16 PATIENT SAMPLES ON TWO COBAS C 503 ANALYTICAL UNITS. THE CUSTOMER PROVIDED AN EXAMPLE OF DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED. THE INITIAL RESULT FROM ANALYZER SERIAL NUMBER (B)(6) WAS 39.7 MG/DL ACCOMPANIED BY A FLAG INDICATING THE VALUE IS ABOVE THE LINEARITY/MEASURING RANGE OF THE ASSAY. THE CUSTOMER QUESTIONED THE HIGH RESULT WHICH PROMPTED THEM TO REPEAT THE SAMPLE. THE SAMPLE WAS REPEATED ON ANALYZER SERIAL NUMBER (B)(6) AND THE RESULT WAS 16 MG/DL. THE CUSTOMER WAS REPEATED AGAIN ON ANALYZER SERIAL NUMBER (B)(6) AND THE RESULT WAS 9.4 MG/DL. THE NEXT DAY, THE PATIENT HAD A NEW SAMPLE COLLECTED AND TESTED ON ANALYZER SERIAL NUMBER (B)(6) AND THE RESULT WAS 9.7 MG/DL. THE RESULT OF 9.4 MG/DL WAS DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23862464 ↗
• MalfunctionNov 26, 2025Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Incorrect, Inadequate or Imprecise Result or Readings; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE CALCIUM GEN.2 RESULTS FOR 2 PATIENT SAMPLES ON A COBAS 8000 COBAS C 502 MODULE. THIS MEDWATCH WILL COVER CALCIUM. REFER TO MEDWATCH WITH A1 PATIENT IDENTIFIER PT-(B)(6) FOR INFORMATION ON THE ALP RESULTS, MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE LACTATE RESULTS, MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE LDH RESULTS, AND MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE AST RESULTS. THE DOCTOR QUESTIONED THE RESULTS AS THEY WERE HIGH AND DID NOT MATCH THE CLINICAL STATUS OF OUTPATIENTS IN "NORMAL" CONDITION. NO SPECIFIC SAMPLE RESULTS WERE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23657144 ↗
• MalfunctionAug 15, 2025Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE LOW CALCIUM GEN.2 RESULTS FROM THE COBAS 6000 C 501 MODULE. THE SAMPLES WERE REPEATED ON ANOTHER COBAS C501 AT ANOTHER SITE. TWO EXAMPLES WERE PROVIDED. PATIENT 1 INITIAL RESULT WAS 6.0 MG/DL. THE REPEAT RESULT WAS 8.5 MG/DL. PATIENT 2 INITIAL RESULT WAS 7.9 MG/DL. THE REPEAT RESULT WAS 8.4 MG/DL. THE REPEAT RESULTS WERE BELIEVED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22817672 ↗
• MalfunctionJun 24, 2025Non Reproducible Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF A QUESTIONABLE CALCIUM GEN.2 RESULT FROM THE COBAS 8000 COBAS C 502 MODULE. THE INITIAL RESULT WAS 65.51 MG/L, AND THE REPEAT RESULT WAS 92.75 MG/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22318202 ↗
• MalfunctionJun 23, 2025Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem

  THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE RESULTS FOR AN UNSPECIFIED NUMBER OF PATIENT SAMPLES TESTED FOR MULTIPLE PARAMETERS ON TWO COBAS INTEGRA 400 PLUS ANALYZERS. THE CUSTOMER PROVIDED DATA FOR ONE PATIENT SAMPLE THAT HAD DISCREPANT RESULTS WHEN TESTED WITH CALCIUM GEN.2. THE SAMPLE INITIALLY RESULTED IN A CALCIUM VALUE OF 15.33 MG/DL WHEN TESTED ON THE FIRST INTEGRA 400 PLUS ANALYZER. THE SAMPLE WAS REPEATED ON THE SECOND INTEGRA 400 PLUS ANALYZER, RESULTING IN A CALCIUM VALUE OF 17.0 MG/DL. THE SAMPLE WAS THEN REPEATED ON AN UNKNOWN ANALYZER OUTSIDE OF THE LABORATORY, RESULTING IN A CALCIUM VALUE OF 8 MG/DL. THIS VALUE WAS CONSIDERED TO BE CORRECT BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22307972 ↗
• MalfunctionMay 23, 2025Incorrect, Inadequate or Imprecise Result or Readings; Non Reproducible Results; Incorrect, Inadequate or Imprecise Result or Readings; Non Reproducible Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED WITH CALCIUM GEN.2 (CA2) ASSAY ON A COBAS 4000 C311 STAND ALONE SYSTEM. INITIAL RESULT: 12.9 MG/DL (TESTED ON C311). THE PATIENT QUESTIONED THE INITIAL RESULT, AND THE SAMPLE WAS REPEATED. 1ST REPEAT RESULT: 13.9 MG/DL (TESTED ON COBAS INTEGRA ANALYZER). ON (B)(6) 2025, THE SAMPLE WAS REPEATED: 2ND AND 3RD REPEAT RESULTS WERE 8.9 MG/DL AND 8.8 MG/DL (TESTED ON C311). 4TH REPEAT RESULT: 9.3 MG/DL (TESTED ON COBAS INTEGRA ANALYZER). 5TH REPEAT RESULT: 8.9 MG/DL (TESTED ON COBAS INTEGRA ANALYZER AND PROCESSED AFTER PERFORMING A NEW CALIBRATION). THE REPEAT RESULTS OBTAINED ON (B)(6) 2025 WERE DEEMED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22079023 ↗
• MalfunctionMar 31, 2025Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE RESULTS FOR AN UNSPECIFIED NUMBER OF PATIENT SAMPLES TESTED WITH CALCIUM GEN.2 ON A COBAS 8000 C 502 MODULE. THE CUSTOMER NOTED THE ISSUE WAS PREVIOUSLY RESOLVED BY REPLACING A DEIONIZER FILTER, BUT IT HAS OCCURRED AGAIN. THE EXACT VALUES WERE NOT PROVIDED. THE INITIAL VALUES WERE NOT IN LINE WITH THE PREVIOUS HISTORY OF THE PATIENTS. THE CUSTOMER STATED THE SAMPLES WERE REPEATED ON A DIFFERENT INSTRUMENT. THE RERUN RESULTS WERE HALVED WHEN COMPARED TO THE INITIAL RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21729740 ↗
• MalfunctionMar 28, 2025Low Test Results; Low Test Results

  THE CUSTOMER STATED THEY RECEIVED QUESTIONABLE RESULTS FOR AN UNSPECIFIED NUMBER OF PATIENT SAMPLES TESTED WITH CALCIUM GEN.2 ON A COBAS 6000 C 501 ANALYZER. THE CUSTOMER STATED THAT THEY PERFORMED MAINTENANCE AND LOADED SYSTEM REAGENTS. CALIBRATION AND CONTROLS PASSED. THEY BEGAN RUNNING PATIENT SAMPLES, BUT NOTICED THAT CALCIUM VALUES WERE LOWER THAN EXPECTED. THE CUSTOMER THEN LOADED A NEW REAGENT PACK AND CONTROLS RECOVERED WITHIN RANGE. PATIENT SAMPLES WERE REPEATED, BUT THEY WERE STILL GETTING THE SAME LOW RESULTS. THE CUSTOMER THEN BORROWED A REAGENT PACK FROM ANOTHER SITE AND REPEATED PATIENT SAMPLES USING IT. THE PACK FROM THE OTHER SITE GENERATED EXPECTED PATIENT VALUES. THE CUSTOMER PROVIDED ONE EXAMPLE OF A SAMPLE WITH DISCREPANT CALCIUM RESULTS. THE SAMPLE RESULTED IN A CALCIUM VALUE OF 5.6 MG/DL WHEN USING THE CUSTOMER'S REAGENT PACK. WHEN TESTED USING THE PACK FROM THE OTHER SITE, THE CALCIUM RESULT WAS 7.8 MG/DL. THE REPEAT VALUE WAS DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21718475 ↗
• MalfunctionJan 29, 2025Low Test Results; Low Test Results

  THERE WAS AN ALLEGATION OF A QUESTIONABLE RESULT CALCIUM GEN. 2 FROM THE COBAS 6000 C (501) MODULE. THE INITIAL RESULT WAS 1.38 MG/DL, AND THE REPEAT RESULT FROM A DIFFERENT C501 ANALYZER WAS 8.34 MG/DL. THE REPEAT RESULT WAS DEEMED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21264879 ↗
• MalfunctionAug 22, 2024Incorrect Measurement; Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results; Incorrect Measurement; Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results

  WE RECEIVED AN ALLEGATION OF QUESTIONABLE RESULTS FOR APPROXIMATELY 5 PATIENT SAMPLES TESTED FOR CALCIUM GEN. 2 (CA2) ON A COBAS 6000 C (501) MODULE. DISCREPANT RESULTS WERE PROVIDED FOR 1 PATIENT SAMPLE. THE INITIAL RESULT WAS 6.2 MG/DL. THE REPEAT RESULT WAS 10.3 MG/DL. THE SAMPLE WAS REPEATED AS THE INITIAL RESULT WAS CRITICAL AND INCONSISTENT WITH THE PATIENT¿S PREVIOUS RESULTS. THE REPEAT RESULT WAS BELIEVED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20035676 ↗
• MalfunctionAug 15, 2024Low Test Results; Low Test Results

  WE RECEIVED AN ALLEGATION OF A DISCREPANT LOW RESULT FOR 1 PATIENT SAMPLE TESTED FOR CALCIUM GEN. 2 (CA2) ON A COBAS 6000 C (501) MODULE. THE INITIAL RESULT WAS 6.48 MG/DL. THE CUSTOMER NOTICED THE RESULT WAS LOW AND REPEATED THE SAMPLE. THE REPEAT RESULT WAS 8.8 MG/DL. THE QUESTIONABLE RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19990848 ↗
• MalfunctionJul 12, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR TWO PATIENT SAMPLES TESTED WITH CALCIUM GEN. 2 ON A COBAS 6000 C 501 ANALYZER. THE CUSTOMER NOTED THAT THE ISSUE OCCURRED AFTER MAINTENANCE WAS PERFORMED ON THE LABORATORY WATER SYSTEM. THE INITIAL VALUES WERE QUESTIONED BY A PHYSICIAN SINCE THEY DID NOT MATCH THE HISTORY OF THE PATIENTS. THE SAMPLES WERE REPEATED AND THE REPEAT VALUES WERE DEEMED CORRECT. CORRECTED REPORTS WERE ISSUED. THE FIRST SAMPLE INITIALLY RESULTED IN A CALCIUM VALUE OF 11.6 MG/DL AND IT REPEATED AS 9.4 MG/DL. THE SECOND SAMPLE INITIALLY RESULTED IN A CALCIUM VALUE OF 12.5 MG/DL AND IT REPEATED AS 10.3 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19732325 ↗
• MalfunctionMay 10, 2024Low Test Results; Low Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE CALCIUM GEN. 2 RESULTS FOR 2 PATIENT SAMPLES ON A COBAS 8000 C 502 MODULE. PATIENT 1: THE INITIAL RESULT WAS 5.6 MG/DL. THE INITIAL RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE WAS REPEATED DUE TO THE INITIAL RESULT HAVING A CRITICAL FLAG. THE REPEATED RESULT WAS 9.6 MG/DL. THE REPEATED RESULT WAS BELIEVED TO BE CORRECT. PATIENT 2: THE INITIAL RESULT WAS 6.1 MG/DL. THE INITIAL RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THE REPEATED RESULT WAS 9.9 MG/DL. THE REPEATED RESULTS WERE OBTAINED ON ANOTHER ANALYZER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19285123 ↗
• MalfunctionApr 22, 2024High 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 INTEGRA 400 PLUS. THE SAMPLE INITIALLY RESULTED IN A CALCIUM VALUE OF 15.7 MG/DL. THE PATIENT QUESTIONED THE RESULT. THE SAMPLE WAS REPEATED, RESULTING IN A CALCIUM VALUE OF 9.5 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19159667 ↗
• MalfunctionMar 22, 2024Low Test Results; Low Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH CA2 (CALCIUM) ON A COBAS 6000 C 501 ANALYZER. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE INITIALLY RESULTED IN A CALCIUM VALUE OF 6.6 MG/DL. SINCE THE VALUE WAS LOW AND CLOSE TO BEING CONSIDERED A CRITICAL VALUE, THE USER DECIDED TO REPEAT THE SAMPLE. THE SAMPLE WAS REPEATED TWICE, RESULTING IN CALCIUM VALUES OF 9.3 MG/DL AND 9.2 MG/DL. THE REPEAT VALUES WERE DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18963039 ↗
• MalfunctionJan 29, 2024Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE CALCIUM (CA, GEN.2) RESULTS FROM SEVEN PATIENT SAMPLES TESTED ON THE COBAS 6000 C 501 (UL) V. THE INITIAL RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THE RESULTS FAILED DELTA CHECKS PROMPTING THE RERUN OF THE PATIENT SAMPLES ON THEIR OTHER C 501. THE REPORTER WAS ABLE TO PROVIDE THE FOLLOWING EXAMPLES OF DISCREPANT RESULTS: SAMPLE 1 THE INITIAL RESULT FROM THE MODULE WAS 5.0 MG/DL. THE REPEAT RESULT FROM THE OTHER MODULE WAS 8.1 MG/DL. SAMPLE 2 THE INITIAL RESULT FROM THE MODULE WAS 6.5 MG/DL. THE REPEAT RESULT FROM THE OTHER MODULE WAS 8.4 MG/DL. SAMPLE 3 THE INITIAL RESULT FROM THE MODULE WAS 6.5 MG/DL. THE REPEAT RESULT FROM THE OTHER MODULE WAS 9.1 MG/DL. SAMPLE 4 THE INITIAL RESULT FROM THE MODULE WAS 7.2 MG/DL. THE REPEAT RESULT FROM THE OTHER MODULE WAS 8.9 MG/DL. SAMPLE 5 THE INITIAL RESULT FROM THE MODULE WAS 7.5 MG/DL. THE REPEAT RESULT FROM THE OTHER MODULE WAS 9.1 MG/DL. THE REPEAT RESULTS WERE DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18594580 ↗
• MalfunctionJan 17, 2024Low Test Results; Low Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE GEN.2 ISE INDIRECT FOR NA AND K, ALB2 ALBUMIN GEN.2, TP2 TOTAL PROTEIN GEN.2, AND CREP2 CREATININE PLUS VER.2 RESULTS FOR 2 PATIENT SAMPLES ON A COBAS INTEGRA 400 PLUS ANALYZER. FOR SAMPLE 1, THE INITIAL NA RESULT WAS 138.5 MMOL/L WITH FLAG, THE INITIAL ALB2 RESULT WAS 1.3 G/L WITH FLAG, AND THE INITIAL TP2 RESULT WAS 0.7 G/DL WITH FLAG. THE SAMPLE WAS SENT TO ANOTHER LABORATORY AND THE REPEAT NA RESULT WAS 132 MMOL/L, THE REPEAT ALBUMIN RESULT WAS 3.7 G/L, AND THE REPEAT TOTAL PROTEIN RESULT WAS 6.6 G/DL. FOR SAMPLE 2, THE INITIAL CREATININE RESULT WAS 0.13 MG/DL WITH FLAG AND THE INITIAL K RESULT WAS 3.7 MMOL/L. THE SAMPLE WAS SENT TO ANOTHER LABORATORY AND THE REPEAT CREATININE RESULT WAS 1.17 MG/DL AND THE REPEAT K RESULT WAS 4.3 MMOL/L. THE REPEAT RESULTS WERE DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18526838 ↗
• MalfunctionDec 15, 2023Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results; Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 3 PATIENTS' PLASMA SAMPLES TESTED WITH CALCIUM GEN.2 (CA2) ASSAY ON A COBAS 6000 C501 ANALYZER. SAMPLE 1: INITIAL RESULT: 0.24 MMOL/L. REPEAT RESULT: 2.33 MMOL/L. SAMPLE 2: INITIAL RESULT: 0.23 MMOL/L. REPEAT RESULT: 2.30 MMOL/L. SAMPLE 3: INITIAL RESULT: 0.23 MMOL/L. REPEAT RESULT: 2.31 MMOL/L. TWO OUT OF THE THREE RESULTS WERE NOT REPORTED OUTSIDE THE LABORATORY. THE REPEAT RESULTS WERE DEEMED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18335910 ↗
• MalfunctionDec 5, 2023High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF A QUESTIONABLE CALCIUM (CA, GEN.2) RESULT FROM THE COBAS 6000 C 501 ANALYZER. THE INITIAL RESULT WAS 11.8 MG/DL AND THE REPEAT RESULT WAS 9.3 MG/DL. THE QUESTIONABLE RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THE REPEAT RESULT WAS BELIEVED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18266503 ↗
• MalfunctionOct 24, 2023Low Test Results; Low Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE CA2 CALCIUM GEN.2 RESULTS FOR 2 PATIENT SAMPLES ON A COBAS 6000 C (501) MODULE. THE INITIAL RESULTS WERE DEEMED CRITICAL AND ACCOMPANIED BY DELTA CHECK FLAGS, WHICH PROMPTED THE CUSTOMER TO REPEAT THE SAMPLES. FOR SAMPLE 1, THE INITIAL CA2 RESULT WAS 5.7 MG/DL. THE SAMPLE WAS REPEATED ON ANOTHER ANALYZER AND THE RESULT WAS 8.4 MG/DL. FOR SAMPLE 2, THE INITIAL CA2 RESULT WAS 6.4 MG/DL. THE SAMPLE WAS REPEATED ON ANOTHER ANALYZER AND THE RESULT WAS 9.3 MG/DL. THE REPEAT RESULTS WERE DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17995402 ↗
• MalfunctionSep 18, 2023Low Test Results; Low Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE RESULTS FOR TWO PATIENT SAMPLES TESTED WITH CA2 (CALCIUM) ON A COBAS 4000 C311 STAND ALONE SYSTEM. THE FIRST PATIENT SAMPLE INITIALLY RESULTED IN A CALCIUM VALUE OF 4.5 MG/DL. THE DOCTOR QUESTIONED THE RESULT. THE SAME SAMPLE WAS REPEATED, RESULTING IN A VALUE OF 9.2 MG/DL. THE REPEAT VALUE WAS DEEMED CORRECT. THE SECOND PATIENT SAMPLE RESULTED IN A CALCIUM VALUE OF 5.3 MG/DL. THE DOCTOR QUESTIONED THE RESULT. A SECOND SAMPLE WAS THEN COLLECTED FROM THIS PATIENT AND THIS SAMPLE RESULTED IN A CALCIUM VALUE OF 8.7 MG/DL. THE REPEAT MEASUREMENT WAS DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17769186 ↗
• MalfunctionJul 18, 2023Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH CA2 ON A COBAS 6000 C 501 MODULE. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE INITIALLY RESULTED IN A CALCIUM VALUE OF 10.30 MG/DL AND IT REPEATED AS 8.34 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17344321 ↗
• MalfunctionJun 16, 2023Low Test Results; Low Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH CA2 CALCIUM GEN.2 ON A COBAS 6000 C (501) MODULE. THE SAMPLE INITIALLY RESULTED IN A CALCIUM VALUE OF 6.7 MG/DL AND THIS VALUE WAS REPORTED OUTSIDE OF THE LABORATORY. THE DOCTOR QUESTIONED THE RESULT. THE SAMPLE WAS REPEATED ON A SECOND ANALYZER, RESULTING IN A VALUE OF 9.4 MG/DL. THE REPEAT VALUE WAS DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17145378 ↗
• MalfunctionMay 12, 2023High Test Results; High Test Results

  THE INITIAL REPORTER QUESTIONED HIGH RESULTS FOR "OVER 100" PATIENT SAMPLES TESTED FOR CA2 CALCIUM GEN.2 (CA2) ON A COBAS 6000 C (501) MODULE. THE CUSTOMER RE-CALIBRATED THE INSTRUMENT AND REPEATED PATIENT SAMPLES AND OBTAINED "NORMAL" RESULTS. DISCREPANT RESULTS WERE PROVIDED FOR 2 PATIENT SAMPLES. "PATIENT 2" INITIAL RESULT WAS 12.2 MG/DL. THE REPEAT RESULT WAS 9.8 MG/DL. "PATIENT 4" INITIAL RESULT WAS 12.4 MG/DL. THE REPEAT RESULT WAS 10.2 MG/DL. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE C501 MODULE SERIAL NUMBER WAS (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16919269 ↗
• MalfunctionMay 9, 2023Unable to Obtain Readings; Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results; Unable to Obtain Readings; Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results

  THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED FOR CA2 CALCIUM GEN.2 (CA2) ON A COBAS 8000 C 502 MODULE. THE INITIAL RESULT WAS 5.7 MG/DL WITH A DATA FLAG. THE SAMPLE WAS AUTOMATICALLY REPEATED BY THE INSTRUMENT AND THE RESULT WAS 5.7 MG/DL. THIS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY WHERE REPEAT TESTING WAS REQUESTED. THE REPEAT RESULT WAS 10.3 MG/DL. THIS RESULT WAS BELIEVED TO BE CORRECT. THE C502 MODULE SERIAL NUMBER WAS (B)(6) .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16893869 ↗