Phosphate (Inorganic) ver.2Recalls & reported problems across all models

We found 3 models of Phosphate (Inorganic) ver.2 by Roche Diagnostics GmbH in the FDA's device registry (GUDID). Together they are named in 20 adverse event reports in the FDA's MAUDE database, received between Oct 14, 2021 and Sep 11, 2026 — classified as 20 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (8 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 Phosphate (Inorganic) ver.2 problems

Phosphate (Inorganic) ver.2 models

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

• Phosphate (Inorganic) ver.2 03183793122

  Phosphomolybdate (colorimetric), inorganic phosphorus
  11 reports
• Phosphate (Inorganic) ver.2 5171377190

  Phosphomolybdate (colorimetric), inorganic phosphorus
  5 reports
• Phosphate (Inorganic) ver.2 08058610190

  Phosphomolybdate (colorimetric), inorganic phosphorus
  4 reports

Recent Phosphate (Inorganic) ver.2 adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 11, 2026High Test Results

  There was an allegation of questionable Phosphate (Inorganic) ver.2 results for multiple patient samples on a cobas 8000 cobas c 701 module. The doctor questioned the initial results with prompted the customer to repeat the samples.On (b)(6) 2026, the customer observed multiple patient sample results initially greater than 4 mmol/L, and upon repeat were 1 mmol/L or lower. On (b)(6) 2026, the customer again observed 3 patient sample results initially between 2 and 5 mmol/L, and upon repeat, around 1 mmol/L. The exact patient results were not provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50734305 ↗
• MalfunctionAug 17, 2026Non Reproducible Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50274576 ↗
• MalfunctionJul 16, 2026Low Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25843288 ↗
• MalfunctionDec 4, 2025Non Reproducible Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE PHOSPHATE (INORGANIC) VER.2 RESULTS FROM THE COBAS 4000 C311 STANDALONE SYSTEM. AN INTERFERENCE WAS SUSPECTED. THE INITIAL RESULT WAS 9.80 MG/DL WITH A DATA FLAG. SINCE THE VALUE WAS PARTICULARLY HIGH AND THERE WERE NO CLINICAL CONDITIONS COMPATIBLE WITH RENAL FAILURE OR SUCH A DEGREE OF HYPERPHOSPHATEMIA, THE TEST WAS REPEATED USING A NEW SAMPLE. THE ELEVATED VALUE WAS CONFIRMED AT 8.10 MG/DL WITH A DATA FLAG. THIS LED TO THE HYPOTHESIS OF INTERFERENCE AND THE COLLECTION OF A NEW SAMPLE. THE FOLLOWING MORNING (B)(6) 2025), A THIRD SAMPLE WAS TAKEN FROM THE PATIENT, YIELDING A RESULT OF 8.55 MG/DL WITH A DATA FLAG. THE SAMPLE WAS SENT TO A SECOND LABORATORY USING THE SAME METHOD ON A C311 ANALYZER. THE RESULT WAS 5.7 MG/DL. THE SAMPLE WAS ALSO TESTED IN ANOTHER LABORATORY, WITH A RESULT OF 3.40 MG/DL. AFTER PREVENTIVE MAINTENANCE WAS PERFORMED AND THE INSTRUMENT CHECKED, THE SAMPLES WERE REPEATED, AND THE RESULTS WERE THE SAME ELEVATED VALUES. NO SPECIFIC DATA WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23714994 ↗
• MalfunctionDec 3, 2025Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem

  THERE WAS AN ALLEGATION OF QUESTIONABLE PHOSPHATE (INORGANIC) VER.2 RESULTS FOR 1 PATIENT SAMPLE ON A COBAS 8000 C702 MODULE. THE CUSTOMER WAS PROMPTED TO REPEAT THE PATIENT SAMPLE AS THEIR QC SHIFTED. THE CUSTOMER RECALIBRATED AND REPEATED QC PRIOR TO REPEATING THE SAMPLE. THE INITIAL RESULT WAS 1.5 MG/DL. THE REPEAT RESULT WAS 1.0 MG/DL. THE REPEAT RESULT WAS DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23706931 ↗
• MalfunctionNov 10, 2025Non Reproducible Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE PHOSPHATE (INORGANIC) VER.2 RESULTS FOR 5 PATIENT SAMPLES ON A COBAS C 703 ANALYTICAL UNIT. THE CUSTOMER PROVIDED AN EXAMPLE OF DISCREPANT RESULTS FOR 2 PATIENT SAMPLES TESTED. FOR SAMPLE 1, THE INITIAL RESULT WAS 9.5 MG/DL. THE REPEAT RESULT WAS 5.4 MG/DL. FOR SAMPLE 2, THE INITIAL RESULT WAS APPROXIMATELY 8 MG/DL. THE REPEAT RESULT WAS 2 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23512424 ↗
• MalfunctionOct 28, 2025Non Reproducible Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF A QUESTIONABLE PHOSPHATE (INORGANIC) VER.2 ASSAY RESULT FOR A PATIENT SAMPLE TESTED ON A COBAS 6000 C501 MODULE. THE INITIAL RESULT WAS 8.7 MG/DL. THE REPEAT RESULT MEASURED ON A DIFFERENT C501 MODULE WAS 3.9 MG/DL. THE INITIAL RESULT WAS QUESTIONED BY THE DOCTOR AS IT DID NOT ALIGN WITH THE PATIENT¿S CLINICAL CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23406389 ↗
• MalfunctionMay 29, 2025Low Test Results; Low Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE PHOSPHATE (INORGANIC) VER.2 RESULTS FROM THE COBAS 8000 COBAS C 502 MODULE. PATIENT 1'S INITIAL RESULT ON (B)(6) 2025 WAS 6.8 MG/DL. A REPEAT RESULT ON (B)(6) 2025 WAS 8.3 MG/DL. ANOTHER REPEAT RESULT AFTER A 1:2 DILUTION WAS 3 MG/DL. PATIENT 2'S INITIAL RESULT ON (B)(6) 2025 WAS 8.4 MG/DL. A REPEAT RESULT ON (B)(6) 2025 WAS 8.5 MG/DL. ANOTHER REPEAT RESULT AFTER A 1:2 DILUTION WAS 3.4 MG/DL. THE CUSTOMER IS UNSURE WHICH RESULTS ARE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22104310 ↗
• MalfunctionDec 19, 2024Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED FOR PHOSPHORUS (PHOS2) ON A COBAS 8000 C 702 MODULE. THE INITIAL RESULT WAS 0.00 MG/DL. THE OPERATOR REQUESTED REPEAT TESTING. THE REPEAT RESULT WAS 3.79 MG/DL. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20979472 ↗
• MalfunctionOct 3, 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 QUESTIONABLE PHOS2 RESULTS FROM THE COBAS 6000 C501 MODULE. THE INITIAL RESULT WAS 1.2 MMOL/L AND THE REPEAT RESULT WAS 1.57 MMOL/L. THE QUESTIONABLE RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20362223 ↗
• MalfunctionOct 1, 2024Low Test Results; Low Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE RESULTS FOR SAMPLES FROM THE SAME PATIENT TESTED WITH PHOS2 (PHOSPHORUS) ON A COBAS 6000 C501 MODULE AND A COBAS C 503 ANALYTICAL UNIT. AT LEAST 4 SAMPLES FROM THE PATIENT HAVE RESULTED IN PHOSPHORUS VALUES OF < 0.181 MG/DL ACCOMPANIED BY A DATA FLAG WHEN TESTED ON EITHER THE C 501 OR C 503 SYSTEMS. THE RESULTS DID NOT MATCH THE PATIENT'S CLINICAL DIAGNOSIS. DATA WAS PROVIDED FOR ONE SPECIFIC SAMPLE TESTED ON (B)(6) 2024. THIS SAMPLE INITIALLY RESULTED IN A PHOSPHORUS VALUE OF < 0.181 MG/DL ACCOMPANIED BY A DATA FLAG WHEN TESTED ON THE C 501 MODULE. THIS SAMPLE WAS SENT TO ANOTHER SITE WHERE IT WAS TESTED ON A VITROS ANALYZER, RESULTING IN A PHOSPHORUS VALUE OF 1.1 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20348054 ↗
• MalfunctionMar 6, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH PHOS2 (PHOSPHORUS) ON A COBAS 8000 C702 MODULE. THE SAMPLE INITIALLY RESULTED IN A PHOSPHORUS VALUE OF 0.9 MG/DL. DUE TO THE VALUE BEING LOW, THE SAMPLE WAS REPEATED, RESULTING IN A VALUE OF 9.5 MG/DL. THE SAMPLE WAS REPEATED SEVERAL TIMES, BUT NOT ADDITIONAL VALUES WERE PROVIDED. THE 0.9 MG/DL VALUE WAS DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18847427 ↗
• MalfunctionSep 22, 2023Incorrect Measurement; High Test Results; Non Reproducible Results; Incorrect Measurement; High Test Results; Non Reproducible Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE PHOS2 PHOSPHATE (INORGANIC) VER.2 RESULTS FROM AN UNSPECIFIED NUMBER OF PATIENT SAMPLES TESTED ON THE COBAS 4000 C311 STAND ALONE SYSTEM. THE REPORTER STATED THAT THERE WERE NO ISSUES WITH THE PHOSPHATE ASSAY IF IT WAS RUN SEPARATELY. HOWEVER, WHEN IT WAS RUN WITH OTHER ASSAYS, THE RESULTS WOULD BE QUESTIONABLE AND HIGH. THE FIELD SERVICE REPRESENTATIVE (FSR) INSTRUCTED THE CUSTOMER TO CHANGE THE CELLS AND LAMP AND PERFORM CALIBRATION AND QC. THE ISSUE WAS NOT RESOLVED. IT WAS DETERMINED THAT THE WASH REACTION PART AND WEEKLY MAINTENANCE WERE NOT PERFORMED. THE TASKS WERE PERFORMED AND THE QC WAS ACCEPTABLE. HOWEVER, THE ISSUE WITH THE PATIENT RESULTS PERSISTED. THE REPORTER WAS ABLE TO PROVIDE ONE EXAMPLE OF DISCREPANT RESULTS: THE INITIAL RESULT WAS 4.11 MMOL/L. THE REPEAT RESULT WAS 1.03 MMOL/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17798238 ↗
• MalfunctionFeb 17, 2023Low Test Results; Low Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH PHOS2 PHOSPHATE (INORGANIC) VER.2 ON A COBAS 6000 C (501) MODULE (SERIAL NUMBER (B)(4) ). NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE INITIALLY RESULTED IN A PHOSPHATE VALUE OF 1.0 MG/DL WITH A DATA FLAG. THE SAMPLE WAS REPEATED, RESULTING IN A VALUE OF 3.2 MG/DL AND THIS VALUE WAS DEEMED CORRECT AND REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16398333 ↗
• MalfunctionFeb 10, 2023Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Incorrect, Inadequate or Imprecise Result or Readings; High Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH PHOS2 PHOSPHATE (INORGANIC) VER.2 ON A COBAS 6000 C (501) MODULE. THE SAMPLE INITIALLY RESULTED IN A PHOSPHATE VALUE OF 0.30 MG/DL ACCOMPANIED BY A DATA FLAG INDICATING A HIGH ABSORBANCE VALUE. THE SAMPLE WAS AUTOMATICALLY REPEATED WITH DECREASED SAMPLE VOLUME, RESULTING IN A VALUE OF 17.51 MG/DL WITH A DATA FLAG. THE 17.51 MG/DL VALUE WAS REPORTED OUTSIDE OF THE LABORATORY. THE NEXT DAY, THE PATIENT HAD A SECOND SAMPLE COLLECTED AND IT RESULTED IN AN INITIAL VALUE OF 0.30 MG/DL ACCOMPANIED BY A DATA FLAG INDICATING A HIGH ABSORBANCE VALUE. THE SAMPLE WAS AUTOMATICALLY REPEATED WITH DECREASED SAMPLE VOLUME, RESULTING IN A VALUE OF 17.84 MG/DL ACCOMPANIED BY A DATA FLAG INDICATING DECREASED SAMPLE VOLUME. AN ALIQUOT OF THE FIRST SAMPLE WAS SENT TO ANOTHER LABORATORY WHERE IT WAS TESTED ON AN AU8000 SYSTEM, RESULTING IN A VALUE OF 5.1 MG/DL. THE VALUE OF 5.1 MG/DL WAS DEEMED CORRECT. THE SERIAL NUMBER OF THE C 501 ANALYZER IS (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16350110 ↗

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