Phosphate (Inorganic) ver.2 03183793122Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 04015630918973), received between Oct 14, 2021 and Aug 17, 2026 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (5 reports).

7 other recalls cover devices cleared under the same FDA submission (K951595); they may or may not involve this specific model.

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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 17, 2026Non Reproducible Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50274576 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionDec 13, 2022Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH THE PHOS2 (PHOSPHATE (INORGANIC) VER.2) ASSAY ON A COBAS 6000 C501 MODULE. THE REPORTER ALSO MENTIONED THEY HAVE QUALITY CONTROL ISSUES IN THE LABORATORY. THE SAMPLE INITIALLY RESULTED IN A PHOS2 VALUE OF AROUND 60 MG/DL. THE SAMPLE WAS REPEATED, RESULTING IN A PHOS2 VALUE OF AROUND 30 MG/DL. NO QUESTIONABLE RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE PHOS2 REAGENT LOT WAS 67081901 WITH AN EXPIRATION DATE OF 31-JAN-2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15969016 ↗
• MalfunctionOct 14, 2021Low Test Results; Low Test Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE RESULTS FOR PHOS2 PHOSPHATE (INORGANIC) VER.2 TESTED ON A COBAS 6000 C (501) MODULE. FROM (B)(6) 2021, 38 PATIENT SAMPLES WITH LOW PHOSPHATE RESULTS WERE REPORTED OUTSIDE THE LABORATORY. ON (B)(6) 2021, THE QC WAS NOTED TO BE VERY LOW. THE REPORTER REPLACED THE REAGENT PACK WITH THE SAME LOT NUMBER IN THE ANALYZER, RECALIBRATED AND RERAN THE QC. SHE THEN RERAN THE SAME PATIENT SAMPLES ON THE ANALYZER FOR CORRECTION. THE REPORTER WAS ABLE TO PROVIDE AN EXAMPLE OF DISCREPANT RESULTS FOR ONE PATIENT SAMPLE. ON (B)(6) 2021, THE INITIAL RESULT WAS 0.7 MG/DL (THE EXACT DATE OF SAMPLE PROCESSING WAS NOT CLEARLY STATED, BUT (B)(6) 2021 WAS USED AS THIS WAS THE DATE THE SPECIMEN WAS COLLECTED). ON (B)(6) 2021, THE REPEAT RESULT WAS 3.0 MG/DL. THE REPEAT RESULT WAS DEEMED TO BE CORRECT. THE C501 MODULE SERIAL NUMBER WAS (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12631537 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K951595. One submission often covers many models, so check the product and lot details in each record.

• Z-1675-2021 · Apr 26, 2021 · Open, Classified
  IRON GEN 2: ROCHE COBAS INTEGRA ANALYZER, REAGENT CASSETTES, Catalog#: 03183696122 - Product Usage: In vitro test for the quantitative determination of iron in human serum and plas
• Z-0100-2017 · Jul 15, 2016 · Terminated
  Roche COBAS INTEGRA 800 /800 CTS Analyzer Analyzer, Chemistry (Photometric, Discrete for Clinical use Product Usage: The system cobas p612 is a computer-controlled stand-alone sys
• Z-0168-2014 · Sep 16, 2013 · Terminated
  COBAS INTEGRA 800 Analyzer with software 9864.C2 Cobas. COBAS Part Numbers 28122474001, 28122474692, 04559126001, 04589459970 corresponding to the Analyzer with or without closed
• Z-0696-2013 · Nov 19, 2012 · Terminated
  Roche COBAS INTEGRA 400 and 400 plus Analyzer, an in vitro diagnostic analyzer.
• Z-0007-2009 · Jun 11, 2008 · Terminated
  Roche Diagnostics IRON2, Iron Gen. 2, COBAS INTEGRA, cobas c systems, Roche Diagnostics, Indianapolis, IN.; 03183696122. An in-vitro diagnostic reagent system intended for use on
• Z-0012-2009 · Jun 11, 2008 · Terminated
  Roche Diagnostics NAPA2, N-Acetyl-Procainamide, COBAS INTEGRA, Roche Diagnostics, Indianapolis, IN.; 20737852322. An in-vitro diagnostic reagent system intended for use on COBAS I
• Z-0667-03 · Feb 13, 2003 · Terminated
  COBAS INTEGRA Creatinine Jaffe for use on the INTEGRA 400, 700 and 800 analyzers; system ID # 0764345, catalog # 20764345