Calcium Gen2Recalls & reported problems across all models

We found 2 models of Calcium Gen2 by Roche Diagnostics GmbH in the FDA's device registry (GUDID). Together they are named in 70 adverse event reports in the FDA's MAUDE database, received between Jul 17, 2018 and Mar 30, 2026 — classified as 70 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (35 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Calcium Gen2 problems

Calcium Gen2 models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Calcium Gen2 5061482190

  TITRIMETRIC WITH EDTA AND INDICATOR, CALCIUM
  36 reports
• Calcium Gen2 5168449190

  TITRIMETRIC WITH EDTA AND INDICATOR, CALCIUM
  34 reports

Recent Calcium Gen2 adverse event reports

The 15 most recent reports across all models, 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 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 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 ↗
• 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 ↗

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