Phosphate (Inorganic) ver.2 08058610190Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613336121481), received between Jul 12, 2022 and Jul 16, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Low 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 16, 2026Low Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25843288 ↗
• 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 ↗
• MalfunctionDec 14, 2022High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED FOR PHOSPHATE (INORGANIC) VER.2 (PHOS2) ON A COBAS PRO C 503 ANALYTICAL UNIT. THE INITIAL RESULT WAS 15.6 MG/DL. THIS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE REPEAT RESULT WAS 8.60 MG/DL. THE PHOS2 REAGENT LOT NUMBER AND EXPIRATION DATE WERE NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15975618 ↗
• MalfunctionJul 12, 2022Low 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 C 503 ANALYTICAL UNIT (SERIAL NUMBER (B)(4)). NO INCORRECT RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE INITIALLY RESULTED IN A PHOSPHORUS VALUE OF 2.69 MG/DL ACCOMPANIED BY A DATA FLAG INDICATING ATYPICAL KINETIC BEHAVIOR. THE SAMPLE WAS REPEATED, RESULTING IN A PHOSPHORUS VALUE OF 2.68 MG/DL ACCOMPANIED BY A DATA FLAG INDICATING ATYPICAL KINETIC BEHAVIOR. THE SAMPLE WAS DILUTED 1:3 AND REPEATED, RESULTING IN A PHOSPHORUS VALUE OF 2.33 MG/DL ACCOMPANIED BY A DATA FLAG. THE SAMPLE WAS REPEATED AGAIN AT DECREASED SAMPLE VOLUME, RESULTING IN A PHOSPHORUS VALUE OF 2.55 MG/DL ACCOMPANIED BY A DATA FLAG INDICATING ATYPICAL KINETIC BEHAVIOR. THE SAMPLE WAS THEN REPEATED ON A SECOND ANALYZER AT DECREASED SAMPLE VOLUME, RESULTING IN A PHOSPHORUS VALUE OF 3.54 MG/DL. THIS VALUE WAS DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14984854 ↗