Phosphate (Inorganic) ver.2 5171377190Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04015630925094), received between Jan 25, 2023 and Sep 11, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “High Test Results” (2 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 5 most recent of 5 reports, 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionJan 25, 2023No Device Output; High Test Results; No Device Output; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE PHOSPHORUS GEN.2 RESULTS FOR ONE PATIENT FROM COBAS 8000 C702 MODULE SERIAL NUMBER (B)(4). THE CUSTOMER ALLEGED INTERFERENCE IN THE SAMPLES. ON (B)(6) 2022, THE RESULT WAS 9.80 MG/DL. THE SAMPLE WAS REPEATED AND THE SAME RESULT WAS OBTAINED. ON (B)(6) 2022, THE RESULT FROM A NEW SAMPLE WAS 9.58 MG/DL. THE QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16241679 ↗