VITROS 6802893Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10758750006250), received between Apr 24, 2023 and Oct 31, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “High Test Results” (4 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. How this data works · Data updated Oct 13, 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.

• MalfunctionOct 31, 2024High Test Results; High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED VITROS INTACT PTH (IPTH) RESULTS WERE OBTAINED FROM MULTIPLE AMERICAN PROFICIENCY INSTITUTE (API) PROFICIENCY SAMPLES AS WELL AS BIORAD QUALITY CONTROL MATERIAL WHEN TESTED ON A VITROS 5600 INTEGRATED SYSTEM USING VITROS IPTH REAGENT LOT: 1950. API SAMPLE IAS 06 RESULT OF 94.9 PG/ML VS. THE EXPECTED RESULT OF 67.97 PG/ML API SAMPLE IAS 07 RESULT OF 28.7 PG/ML VS. THE EXPECTED RESULT OF 19.94 PG/ML API SAMPLE IAS 08 RESULT OF 284.6 PG/ML VS. THE EXPECTED RESULT OF 211.32 PG/ML API SAMPLE IAS 09 RESULT OF 154.2 PG/ML VS. THE EXPECTED RESULT OF 112.98 PG/ML API SAMPLE IAS 10 RESULT OF 229.5 PG/ML VS. THE EXPECTED RESULT OF 168.3 PG/ML BIORAD LEVEL 1 RESULTS OF 31.4 PG/ML VERSUS THE EXPECTED RESULT OF 23.6 PG/ML BIORAD LEVEL 2 RESULTS OF 288.5 AND 280.7 PG/ML VERSUS THE EXPECTED RESULT OF 215 PG/ML BIORAD LEVEL 3 RESULTS OF 963.2, 904.7, 885.5, 895.7, 913.8, 934.3, 936.5, 911.7, 936.4, 925.8, 876.2, 913.3, 884.3, 885.8, 872.5, 959.8, 934.7, 930.3, 919.6, 895.5, 870.9, 870.9, 886.3, 935.5, 909.1, 895.8, 901.5, AND 905.9 PG/ML VS. THE EXPECTED RESULT OF 664.0 PG/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20579657 ↗
• MalfunctionOct 10, 2024High Test Results; High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED VITROS INTACT PTH (IPTH) RESULTS WERE OBTAINED WHILE PROCESSING A SINGLE PATIENT SAMPLE AND A SINGLE LEVEL OF NON-VITROS BIORAD LIQUICHEK SPECIALTY IMMUNOASSAY CONTROL FLUID WITH VITROS IPTH LOT 2000 ON A VITROS XT 7600 INTEGRATED SYSTEM. BIORAD LOT 65000, LEVEL 2 RESULT OF 282.6 PG/ML VERSUS THE EXPECTED RESULT OF 211.4 PG/ML PATIENT SAMPLE A IPTH RESULT OF 55.2 PG/ML VERSUS THE EXPECTED RESULT OF 41.0 PG/ML BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. THE HIGHER THAN EXPECTED VITROS IPTH RESULTS WERE OBTAINED FROM A CORRELATION SAMPLE AS WELL AS A BIORAD QC FLUID AND RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO REPORTED ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER (B)(4) AND REPORTABILITY ASSESSMENT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20422843 ↗
• MalfunctionMar 5, 2024High Test Results; High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT DISCORDANT, HIGHER THAN EXPECTED VITROS IPTH (LOT 1860) RESULTS WERE OBTAINED WHEN MULTIPLE PATIENT SAMPLES WERE TESTED ON A VITROS XT7600 INTEGRATED SYSTEM. THE RESULTS WERE DISCORDANT WHEN COMPARED TO VITROS IPTH2 RESULTS FOR THE SAME PATIENT SAMPLES. IN ADDITION, A DISCORDANT, LOWER THAN EXPECTED VITROS IPTH2 (LOT 0020) RESULTS WAS OBTAINED FROM A SINGLE PATIENT SAMPLE WHEN TESTED ON THE SAME VITROS XT7600 INTEGRATED SYSTEM. THE RESULTS WERE DISCORDANT WHEN COMPARED TO VITROS IPTH RESULTS FOR THE SAME PATIENT SAMPLE. PATIENT 1, VITROS IPTH LOT 1860 RESULT OF 75.02 PG/ML VERSUS THE VITROS IPTH2 RESULTS OF 42.08 AND 40.32 PG/ML PATIENT 2, VITROS IPTH LOT 1860 RESULT OF 72.83 PG/ML VERSUS THE VITROS IPTH2 RESULTS OF 50.17 AND 49.44 PG/ML PATIENT 3, VITROS IPTH LOT 1860 RESULT OF 123.50 PG/ML VERSUS THE VITROS IPTH2 RESULTS OF 68.26 AND 68.39 PG/ML PATIENT 4, VITROS IPTH LOT 1860 RESULT OF 84.96 PG/ML VERSUS THE VITROS IPTH2 RESULTS OF 52.50 AND 51.93 PG/ML PATIENT 5, VITROS IPTH LOT 1860 RESULT OF 128.53 PG/ML VERSUS THE VITROS IPTH2 RESULTS OF 78.95 AND 77.78 PG/ML PATIENT 6, VITR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18841187 ↗
• MalfunctionApr 24, 2023High Test Results; High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED VITROS INTACT PTH (IPTH) RESULTS WERE OBTAINED FROM VITROS IPTH REAGENT LOT 1650 TESTED WITH TWO LEVELS OF NON-VITROS SERONORM CONTROL FLUIDS, LOT 2010905, TESTED ON A VITROS XT7600 INTEGRATED SYSTEM. SERONORM LEVEL 1 RESULTS OF 27.3 AND 26.6 PG/ML VS. THE EXPECTED RESULT OF 19.0 PG/ML. SERONORM LEVEL 2 RESULTS OF 141.9 AND 139.6 PG/ML VS. THE EXPECTED RESULT OF 90.2 PG/ML. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. THE HIGHER THAN EXPECTED VITROS IPTH RESULTS WERE OBTAINED FROM NON-PATIENT QUALITY CONTROL FLUIDS AND WERE NOT REPORTED FROM THE LABORATORY. THE CUSTOMER MADE NO INDICATION THAT PATIENT SAMPLES WERE AFFECTED AND THERE WAS NO REPORTED ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER (B)(4) AND REPORTABILITY ASSESSMENT 601564.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16799905 ↗