VITROS 6900052Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10758750032709), received between Mar 5, 2024 and May 12, 2026 — classified as 21 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (18 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 12, 2026High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED VITROS IPTH II (IPTH2) RESULTS WERE OBTAINED FROM NON-VITROS BIORAD QUALITY CONTROLS AND VITROS IPTH II QUALITY CONTROLS PROCESSED USING VITROS IMMUNODIAGNOSTIC PRODUCTS INTACT PTH II REAGENT LOT 0270 ON A VITROS 5600 INTEGRATED SYSTEM. BIORAD LOT 1003750 L1 RESULT OF 30.03 PG/ML VS AN EXPECTED RESULT OF 21.4 PG/ML BIORAD LOT 1003750 L3 RESULT OF 581.6 PG/ML VS AN EXPECTED RESULT OF 420.0 PG/ML VITROS IPTH II CONTROL LOT 0190 L1 RESULTS OF 42.6, 42.93, 43.06, 43.45 AND 43.20 PG/ML VS AN EXPECTED RESULT OF 30.7 PG/ML VITROS IPTH II CONTROL LOT 0190 L2 RESULTS OF 147.28, 147.08, 148.55, 148.23 AND 148.39 PG/ML VS AN EXPECTED RESULT OF 108.5 PG/ML VITROS IPTH II CONTROL LOT 0190 L3 RESULTS OF 705.55, 724.13, 724.99, 715.41 AND 712.13 PG/ML VS AN EXPECTED RESULT OF 521.8 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 IPTH2 RESULTS WERE FROM QUALITY CONTROL FLUIDS AND NO RESULTS WERE REPORTED FROM THE LABORATORY. HOWEVER, THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25149203 ↗
• MalfunctionFeb 9, 2026High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A DISCORDANT HIGHER THAN EXPECTED VITROS INTACT PTH2 RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE WHEN TESTED USING VITROS INTACT PTH2 (IPTH2) REAGENT LOT 0250 ON A VITROS XT 7600 INTEGRATED SYSTEM. THE RESULT WAS CONSIDERED DISCORDANT WHEN COMPARED TO A NON-VITROS SIEMANS ATELLICA (IPTH) METHOD. PATIENT 1, SAMPLE 1 VITROS IPTH2 RESULT OF 632.30 PG/ML (ABOVE THE REFERENCE INTERVAL) VS A SIEMENS RESULT OF 46.5 PG/ML (WITHIN THE REFERENCE INTERVAL). BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE DISCORDANT, HIGHER THAN EXPECTED PATIENT SAMPLE RESULT WAS NOT REPORTED FROM THE LABORATORY. THERE WAS NO ALLEGATION OF HARM AS A RESULT OF THE EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBERS (B)(4) AND REPORTABILITY ASSESSMENT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24290977 ↗
• MalfunctionSep 8, 2025High Test Results; High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A HIGHER-THAN-EXPECTED VITROS INTACT PTH II (IPTH II) QUALITY CONTROL (QC) RESULT WAS OBTAINED WHEN USING NON-VITROS BIORAD LIQUICHEK SPECIALTY IMMUNOASSAY CONTROL LOT 65000 ON A VITROS XT 7600 INTEGRATED SYSTEM. BIORAD LEVEL 3 QC 65000 RESULT OF 480.44 PG/ML VERSUS THE EXPECTED RESULT OF 354.00 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 II RESULT WAS OBTAINED WHEN THE CUSTOMER WAS PROCESSING NON-PATIENT FLUIDS. THE CUSTOMER MADE NO INDICATION THAT ANY PATIENT SAMPLE RESULTS HAD BEEN AFFECTED. THERE WAS NO 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 22994237 ↗
• MalfunctionJul 14, 2025High Test Results; Low Test Results; High Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT THAT HIGHER AND LOWER THAN EXPECTED VITROS IPTH2 RESULTS OCCURRED WHILE PROCESSING PATIENT CORRELATION SAMPLES WHEN COMPARING DATA FROM A METHOD COMPARISON STUDY BETWEEN TWO REAGENT LOTS OF THE VITROS INTACT PTH II (IPTH2) ASSAY AND TWO REAGENT LOTS THE VITROS INTACT PARATHYROID HORMONE (IPTH) ASSAY ON A VITROS XT7600 INTEGRATED SYSTEM. IPTH2 LOT 0080 VERSUS IPTH LOT 2010 CORRELATION SAMPLE 3 VITROS IPTH2 RESULT OF 100.9 PG/ML (ABOVE THE REFERENCE INTERVAL) VS. THE VITROS IPTH RESULT OF 51.7 PG/ML (WITHIN THE REFERENCE INTERVAL). CORRELATION SAMPLE 5 VITROS IPTH2 RESULT OF 12.6 PG/ML (BELOW THE REFERENCE INTERVAL) VS. THE VITROS IPTH RESULT OF 16.9 PG/ML (WITHIN THE REFERENCE INTERVAL). CORRELATION SAMPLE 7 VITROS IPTH2 RESULT OF 41.5 PG/ML (WITHIN THE REFERENCE INTERVAL) VS. THE VITROS IPTH RESULT OF 58.4 PG/ML (ABOVE THE REFERENCE INTERVAL). CORRELATION SAMPLE 8 VITROS IPTH2 RESULT OF 11.8 PG/ML (BELOW THE REFERENCE INTERVAL) VS. THE VITROS IPTH RESULT OF 16.5 PG/ML (WITHIN THE REFERENCE INTERVAL). CORRELATION SAMPLE 12 VITROS IPTH2 RESULT OF 12.5 PG/ML (BELOW THE REFERENCE INTER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22494715 ↗
• MalfunctionJul 11, 2025High Test Results; Low Test Results; High Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT THAT HIGHER AND LOWER THAN EXPECTED VITROS IPTH2 RESULTS OCCURRED WHILE PROCESSING PATIENT CORRELATION SAMPLES WHEN COMPARING DATA FROM A METHOD COMPARISON STUDY BETWEEN TWO REAGENT LOTS OF THE VITROS INTACT PTH II (IPTH2) ASSAY AND TWO REAGENT LOTS THE VITROS INTACT PARATHYROID HORMONE (IPTH) ASSAY ON A VITROS XT7600 INTEGRATED SYSTEM. IPTH2 LOT 0080 VERSUS IPTH LOT 2010 CORRELATION SAMPLE 3 VITROS IPTH2 RESULT OF 100.9 PG/ML (ABOVE THE REFERENCE INTERVAL) VS. THE VITROS IPTH RESULT OF 51.7 PG/ML (WITHIN THE REFERENCE INTERVAL). CORRELATION SAMPLE 5 VITROS IPTH2 RESULT OF 12.6 PG/ML (BELOW THE REFERENCE INTERVAL) VS. THE VITROS IPTH RESULT OF 16.9 PG/ML (WITHIN THE REFERENCE INTERVAL). CORRELATION SAMPLE 7 VITROS IPTH2 RESULT OF 41.5 PG/ML (WITHIN THE REFERENCE INTERVAL) VS. THE VITROS IPTH RESULT OF 58.4 PG/ML (ABOVE THE REFERENCE INTERVAL). CORRELATION SAMPLE 8 VITROS IPTH2 RESULT OF 11.8 PG/ML (BELOW THE REFERENCE INTERVAL) VS. THE VITROS IPTH RESULT OF 16.5 PG/ML (WITHIN THE REFERENCE INTERVAL). CORRELATION SAMPLE 12 VITROS IPTH2 RESULT OF 12.5 PG/ML (BELOW THE REFERENCE INTER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22481730 ↗
• MalfunctionApr 30, 2025Low Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A LOWER-THAN-EXPECTED INTACT PTH II (IPTH II) RESULT WAS OBTAINED WHEN A LEVEL 2 BIORAD QC WAS TESTED USING VITROS IPTH II LOT 0145 ON A VITROS 5600 INTEGRATED SYSTEM. BIORAD LEVEL 2 (LOT 64992) RESULT OF 89.14 PG/ML VERSUS THE PI MEAN RESULT OF 130 PG/ML BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LED TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. THE LOWER-THAN-EXPECTED VITROS IPTH II RESULT WAS OBTAINED WHEN THE CUSTOMER WAS PROCESSING A NON-PATIENT FLUID. THERE HAS BEEN NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) (B)(4) AND REPORTABILITY ASSESSMENT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21937980 ↗
• MalfunctionMar 20, 2025Low Test Results; Low Test Results

  A CUSTOMER CONTACTED THE (B)(6) TO REPORT LOWER THAN EXPECTED VITROS IPTH2 RESULTS HAVE OCCURRED WITH MULTIPLE PATIENT SAMPLES WHEN COMPARING DATA FROM A METHOD COMPARISON STUDY BETWEEN THE VITROS IPTH2 ASSAY AND THE VITROS IPTH ASSAY ON A VITROS 3600 IMMUNODIAGNOSTIC SYSTEM. CORRELATION SAMPLE 2 VITROS IPTH2 RESULT OF 44.4 PG/ML (WITHIN THE REFERENCE INTERVAL) VS. THE VITROS IPTH RESULT OF 64.1 PG/ML (ABOVE THE REFERENCE INTERVAL). CORRELATION SAMPLE 3 VITROS IPTH2 RESULT OF 58.0 PG/ML (WITHIN THE REFERENCE INTERVAL) VS. THE VITROS IPTH RESULT OF 86.5 PG/ML (ABOVE THE REFERENCE INTERVAL). CORRELATION SAMPLE 8 VITROS IPTH2 RESULT OF 41.0 PG/ML (WITHIN THE REFERENCE INTERVAL) VS. THE VITROS IPTH RESULT OF 61.8 PG/ML (ABOVE THE REFERENCE INTERVAL). CORRELATION SAMPLE 17 VITROS IPTH2 RESULT OF 51.0 PG/ML (WITHIN THE REFERENCE INTERVAL) VS. THE VITROS IPTH RESULT OF 74.9 PG/ML (ABOVE THE REFERENCE INTERVAL). CORRELATION SAMPLE 18 VITROS IPTH2 RESULT OF 38.0 PG/ML (WITHIN THE REFERENCE INTERVAL) VS. THE VITROS IPTH RESULT OF 54.4 PG/ML (ABOVE THE REFERENCE INTERVAL). CORRELATION SAMPLE 19 VITROS IPTH2 RESULT OF 42.4 PG/ML (WITHIN THE REFERENCE INTERVAL) VS. THE VITROS IPTH RESULT OF 60.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21654901 ↗
• MalfunctionFeb 26, 2025Low Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED VITROS INTACT PTH2 (IPTH2) RESULTS WERE OBTAINED WHEN PROCESSING A PATIENT SAMPLE CORRELATION. THE RESULTS WERE CONSIDERED DISCORDANT WHEN COMPARED TO VITROS INTACT PTH (IPTH) RESULTS. CORRELATION SAMPLE 2 VITROS IPTH2 RESULT OF 41.90 PG/ML (WITHIN THE REFERENCE INTERVAL) VS. THE VITROS IPTH RESULT OF 78.40 PG/ML (ABOVE THE REFERENCE INTERVAL). CORRELATION SAMPLE 4 VITROS IPTH2 RESULT OF 34.40 PG/ML (WITHIN THE REFERENCE INTERVAL) VS. THE VITROS IPTH RESULT OF 62.20 PG/ML (ABOVE THE REFERENCE INTERVAL). CORRELATION SAMPLE 5 VITROS IPTH2 RESULT OF 32.80 PG/ML (WITHIN THE REFERENCE INTERVAL) VS. THE VITROS IPTH RESULT OF 62.10 PG/ML (ABOVE THE REFERENCE INTERVAL). CORRELATION SAMPLE 7 VITROS IPTH2 RESULT OF 39.10 PG/ML (WITHIN THE REFERENCE INTERVAL) VS. THE VITROS IPTH RESULT OF 68.10 PG/ML (ABOVE THE REFERENCE INTERVAL). CORRELATION SAMPLE 8 VITROS IPTH2 RESULT OF 11.00 PG/ML (BELOW THE REFERENCE INTERVAL) VS. THE VITROS IPTH RESULT OF 19.90 PG/ML (WITHIN THE REFERENCE INTERVAL). CORRELATION SAMPLE 11 VITROS IPTH2 RESULT OF 19.93 PG/ML (WITHIN THE REFERENCE INTE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21468140 ↗
• MalfunctionFeb 10, 2025Low Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED VITROS INTACT PTH II (IPTH2) RESULTS WERE OBTAINED FROM SEVERAL DIFFERENT PATIENT SAMPLES WHEN TESTED USING VITROS IPTH2 REAGENT ON A VITROS XT 7600 INTEGRATED SYSTEM. THE SEVERAL DIFFERENT PATIENT SAMPLES WERE CONSIDERED DISCORDANT WHEN COMPARED TO A NON-VITROS ABBOTT ARCHITECT METHOD. SAMPLE ID: (B)(6), IPTH2 RESULT OF 54.7 PG/ML (WITHIN REFERENCE INTERVAL) VERSUS THE EXPECTED RESULT OF 100.6 PG/ML (ABOVE REFERENCE INTERVAL) SAMPLE ID: (B)(6), IPTH2 RESULT OF 55.7 PG/ML (WITHIN REFERENCE INTERVAL) VERSUS THE EXPECTED RESULT OF 92.6 PG/ML (ABOVE REFERENCE INTERVAL) SAMPLE ID: (B)(6), IPTH2 RESULT OF 42.9 PG/ML (WITHIN REFERENCE INTERVAL) VERSUS THE EXPECTED RESULT OF 79.2 PG/ML (ABOVE REFERENCE INTERVAL) SAMPLE ID: (B)(6), IPTH2 RESULT OF 55.5 PG/ML (WITHIN REFERENCE INTERVAL) VERSUS THE EXPECTED RESULT OF 96.1 PG/ML (ABOVE REFERENCE INTERVAL) SAMPLE ID: (B)(6), IPTH2 RESULT OF 60.3 PG/ML (WITHIN REFERENCE INTERVAL) VERSUS THE EXPECTED RESULT OF 100.7 PG/ML (ABOVE REFERENCE INTERVAL) SAMPLE ID: (B)(6), IPTH2 RESULT OF 61.3 PG/ML (WITHIN REFERENCE INTERVAL) VERS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21345859 ↗
• MalfunctionOct 31, 2024Low Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT DISCORDANT, LOWER THAN EXPECTED INTACT PTH (IPTH) RESULTS WERE OBTAINED WHEN SAMPLES FROM TWO DIFFERENT PATIENTS WERE TESTED USING VITROS IPTH II LOT 0050 ON A VITROS XT 7600 INTEGRATED SYSTEM. THE RESULTS WERE DISCORDANT WHEN COMPARED TO NON-VITROS DIASORIN IPTH RESULTS FOR THE SAME PATIENT SAMPLES. PATIENT 8, VITROS IPTH II RESULT OF 69.75 PG/ML (WITHIN THE RI) VERSUS A DIASORIN IPTH RESULT OF 135 PG/ML (ABOVE THE RI) PATIENT 26, VITROS IPTH II RESULT OF 6 PG/ML (BELOW THE RI) VERSUS A DIASORIN IPTH RESULT OF 14 PG/ML (WITHIN THE RI) BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE DISCORDANT, LOWER THAN EXPECTED VITROS IPTH2 RESULTS WERE OBTAINED WHEN VITROS IPTH2 VALIDATION TESTING WAS BEING PERFORMED AS PART OF A MENU EXPANSION AND THE RESULTS WERE NOT REPORTED FROM THE LABORATORY. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER TWO OF TWO MDRS FOR THIS EVENT. TWO 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS TWO DEVICES WERE INVOLVED. THIS REPORT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20577659 ↗
• MalfunctionOct 31, 2024Low Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT DISCORDANT, LOWER THAN EXPECTED INTACT PTH (IPTH) RESULTS WERE OBTAINED WHEN SAMPLES FROM TWO DIFFERENT PATIENTS WERE TESTED USING VITROS IPTH II LOT 0050 ON A VITROS XT 7600 INTEGRATED SYSTEM. THE RESULTS WERE DISCORDANT WHEN COMPARED TO NON-VITROS DIASORIN IPTH RESULTS FOR THE SAME PATIENT SAMPLES. PATIENT 8, VITROS IPTH II RESULT OF 69.75 PG/ML (WITHIN THE RI) VERSUS A DIASORIN IPTH RESULT OF 135 PG/ML (ABOVE THE RI) PATIENT 26, VITROS IPTH II RESULT OF 6 PG/ML (BELOW THE RI) VERSUS A DIASORIN IPTH RESULT OF 14 PG/ML (WITHIN THE RI) BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE DISCORDANT, LOWER THAN EXPECTED VITROS IPTH2 RESULTS WERE OBTAINED WHEN VITROS IPTH2 VALIDATION TESTING WAS BEING PERFORMED AS PART OF A MENU EXPANSION AND THE RESULTS WERE NOT REPORTED FROM THE LABORATORY. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER ONE OF TWO MDRS FOR THIS EVENT. TWO 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS TWO DEVICES WERE INVOLVED. THIS REPORT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20577509 ↗
• MalfunctionOct 21, 2024High Test Results; Low Test Results; High Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER AND HIGHER THAN EXPECTED VITROS IPTH2 RESULTS HAVE OCCURRED WITH MULTIPLE PATIENT SAMPLES WHEN COMPARING DATA FROM A METHOD COMPARISON STUDY BETWEEN THE VITROS IPTH2 ASSAY AND THE VITROS IPTH ASSAY ON A VITROS XT 7600 INTEGRATED SYSTEM. THE VITROS IPTH2 REFERENCE INTERVAL: 1.5 - 8.0 PMOL/L THE VITROS IPTH REFERENCE INTERVAL: 1.4 - 9.1 PMOL/L J76001152 CORRELATION SAMPLE 2 VITROS IPTH2 RESULT OF 7.70 PMOL/L (WITHIN THE REFERENCE INTERVAL) VS. THE VITROS IPTH RESULT OF 11.52 PMOL/L (ABOVE THE REFERENCE INTERVAL). CORRELATION SAMPLE 7 VITROS IPTH2 RESULT OF 7.30 PMOL/L (WITHIN THE REFERENCE INTERVAL) VS. THE VITROS IPTH RESULT OF 10.88 PMOL/L (ABOVE THE REFERENCE INTERVAL). CORRELATION SAMPLE 21 VITROS IPTH2 RESULT OF 6.11 PMOL/L (WITHIN THE REFERENCE INTERVAL) VS. THE VITROS IPTH RESULT OF 9.96 PMOL/L (ABOVE THE REFERENCE INTERVAL). CORRELATION SAMPLE 27 VITROS IPTH2 RESULT OF 7.08 PMOL/L (WITHIN THE REFERENCE INTERVAL) VS. THE VITROS IPTH RESULT OF 10.66 PMOL/L (ABOVE THE REFERENCE INTERVAL). J76001174 CORRELATION SAMPLE 21 VITROS IPTH2 RESULT OF 6.67 PMOL/L (WITHIN THE REFERE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20492623 ↗
• MalfunctionOct 21, 2024High Test Results; Low Test Results; High Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER AND HIGHER THAN EXPECTED VITROS IPTH2 RESULTS HAVE OCCURRED WITH MULTIPLE PATIENT SAMPLES WHEN COMPARING DATA FROM A METHOD COMPARISON STUDY BETWEEN THE VITROS IPTH2 ASSAY AND THE VITROS IPTH ASSAY ON A VITROS XT 7600 INTEGRATED SYSTEM. THE VITROS IPTH2 REFERENCE INTERVAL: 1.5 - 8.0 PMOL/L THE VITROS IPTH REFERENCE INTERVAL: 1.4 - 9.1 PMOL/L J76001152 CORRELATION SAMPLE 2 VITROS IPTH2 RESULT OF 7.70 PMOL/L (WITHIN THE REFERENCE INTERVAL) VS. THE VITROS IPTH RESULT OF 11.52 PMOL/L (ABOVE THE REFERENCE INTERVAL). CORRELATION SAMPLE 7 VITROS IPTH2 RESULT OF 7.30 PMOL/L (WITHIN THE REFERENCE INTERVAL) VS. THE VITROS IPTH RESULT OF 10.88 PMOL/L (ABOVE THE REFERENCE INTERVAL). CORRELATION SAMPLE 21 VITROS IPTH2 RESULT OF 6.11 PMOL/L (WITHIN THE REFERENCE INTERVAL) VS. THE VITROS IPTH RESULT OF 9.96 PMOL/L (ABOVE THE REFERENCE INTERVAL). CORRELATION SAMPLE 27 VITROS IPTH2 RESULT OF 7.08 PMOL/L (WITHIN THE REFERENCE INTERVAL) VS. THE VITROS IPTH RESULT OF 10.66 PMOL/L (ABOVE THE REFERENCE INTERVAL). J76001174 CORRELATION SAMPLE 21 VITROS IPTH2 RESULT OF 6.67 PMOL/L (WITHIN THE REFERE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20492528 ↗
• MalfunctionOct 17, 2024Low Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED VITROS IPTH2 RESULTS HAVE OCCURRED WITH THREE DIFFERENT PATIENT SAMPLES WHEN COMPARING DATA FROM A METHOD COMPARISON STUDY BETWEEN THE VITROS IPTH2 ASSAY AND THE VITROS IPTH ASSAY ON A VITROS XT 7600 INTEGRATED SYSTEM. CORRELATION SAMPLE 3 VITROS IPTH2 RESULT OF 34.6 PG/ML VS. THE VITROS IPTH RESULT OF 70.8 PG/ML. CORRELATION SAMPLE 13 VITROS IPTH2 RESULT OF 140.2 PG/ML VS. THE VITROS IPTH RESULT OF 253.2 PG/ML. CORRELATION SAMPLE 20 VITROS IPTH2 RESULT OF 34.6 PG/ML VS. THE VITROS IPTH RESULT OF 70.5 PG/ML. THE VARIABILITY OBSERVED BETWEEN THE VITROS IPTH2 AND IPTH ASSAYS IS AN EXPECTED OUTCOME, GIVEN THE LACK OF STANDARDIZATION ACROSS IPTH MEASUREMENT METHODS. DIFFERENCES IN ASSAY DESIGN, ANTIBODY SELECTION, AND VARIOUS CIRCULATING FRAGMENTS CONTRIBUTE TO THE WELL-DOCUMENTED INTER-METHOD DISCREPANCIES IN PTH MEASUREMENT. ORTHO HAD PREVIOUSLY COMMUNICATED (CL2016-196) THAT THE VITROS IPTH ASSAY WAS APPROXIMATELY 20% HIGHER THAN A NON-VITROS ROCHE METHOD. THE VITROS IPTH2 ASSAY HAS ELIMINATED THAT 20% HIGH BIAS. THEREFORE, THERE IS AN EXPECTED 20% BIAS BETWEEN I

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20469768 ↗
• MalfunctionOct 16, 2024Low Test Results; Low Test Results

  THIS SUPPLEMENTAL MDR FILES FOR ADDITIONAL SAMPLES THAT WERE DEEMED REPORTABLE AFTER MEDICAL AFFAIRS CONSULTATION. THE FOLLOWING RESULTS WERE INITIALLY REPORTED BASED ON A KNOWN 20% NEGATIVE BIAS FOR THE VITROS IPTH2 ASSAY WHEN COMPARED TO RESULTS OBTAINED FROM THE VITROS IPTH ASSAY. INITIALLY, THE KNOWN 20% BIAS WAS REMOVED FROM THE VTROS IPTH RESULTS WHEN ASSESSING THE VITROS IPTH2 RESULTS FOR POTENTIAL REPORTING. THE FOLLOWING VITROS IPTH2 RESULTS WERE INITIALLY REPORTED: CORRELATION SAMPLE 3 VITROS IPTH2 RESULT OF 34.6 PG/ML VS. THE VITROS IPTH RESULT OF 70.8 PG/ML. CORRELATION SAMPLE 13 VITROS IPTH2 RESULT OF 140.2 PG/ML VS. THE VITROS IPTH RESULT OF 253.2 PG/ML. CORRELATION SAMPLE 20 VITROS IPTH2 RESULT OF 34.6 PG/ML VS. THE VITROS IPTH RESULT OF 70.5 PG/ML. ON (B)(6) 2024, A MEDICAL CONSULTATION WAS PERFORMED WITH ORTHO MEDICAL SCIENTIFIC & CLINICAL AFFAIRS AND IT WAS DETERMINED THE 20% BIAS SHOULD NOT HAVE BEEN REMOVED WHEN ASSESSING FOR POTENTIAL HEALTH AND SAFETY CRITERIA, WITH THE FOLLOWING RATIONALE: THE IPTH IS NOT STANDARDIZED, SO IT IS EXPECTED TO SEE SOME VARIABILITY IN THE RESULTS. THOUGH THERE IS A KNOWN AVERAGE BIAS OF ~ 20% BETWEEN THE TWO TESTS, THE RANGE OF OB

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20467143 ↗
• MalfunctionAug 23, 2024Low Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED VITROS IPTH2 RESULTS HAVE OCCURRED WITH MULTIPLE PATIENT SAMPLES WHEN COMPARING DATA FROM A METHOD COMPARISON STUDY BETWEEN THE VITROS IPTH2 ASSAY AND THE VITROS IPTH ASSAY ON THREE DIFFERENT VITROS XT 7600 INTEGRATED SYSTEMS. THE VITROS IPTH2 REFERENCE INTERVAL: 14.2 - 75.2 PG/ML. THE VITROS IPTH REFERENCE INTERVAL: 7.5 - 53.5 PG/ML. J76000938 CORRELATION SAMPLE 7 VITROS IPTH2 RESULT OF 44.5 PG/ML (WITHIN THE REFERENCE INTERVAL) VS. THE VITROS IPTH RESULT OF 64.2 PG/ML (ABOVE THE REFERENCE INTERVAL). CORRELATION SAMPLE 11 VITROS IPTH2 RESULT OF 49.9 PG/ML (WITHIN THE REFERENCE INTERVAL) VS. THE VITROS IPTH RESULT OF 72.2 PG/ML (ABOVE THE REFERENCE INTERVAL). CORRELATION SAMPLE 20 VITROS IPTH2 RESULT OF 58.4 PG/ML (WITHIN THE REFERENCE INTERVAL) VS. THE VITROS IPTH RESULT OF 86.6 PG/ML (ABOVE THE REFERENCE INTERVAL). CORRELATION SAMPLE 21 VITROS IPTH2 RESULT OF 62.6 PG/ML (WITHIN THE REFERENCE INTERVAL) VS. THE VITROS IPTH RESULT OF 95.8 PG/ML (ABOVE THE REFERENCE INTERVAL). CORRELATION SAMPLE 22 VITROS IPTH2 RESULT OF 61.9 PG/ML (WITHIN THE REFERENCE INTERVAL)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20057356 ↗
• MalfunctionAug 23, 2024Low Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED VITROS IPTH2 RESULTS HAVE OCCURRED WITH MULTIPLE PATIENT SAMPLES WHEN COMPARING DATA FROM A METHOD COMPARISON STUDY BETWEEN THE VITROS IPTH2 ASSAY AND THE VITROS IPTH ASSAY ON THREE DIFFERENT VITROS XT 7600 INTEGRATED SYSTEMS. THE VITROS IPTH2 REFERENCE INTERVAL: 14.2 - 75.2 PG/ML. THE VITROS IPTH REFERENCE INTERVAL: 7.5 - 53.5 PG/ML. J76000938 CORRELATION SAMPLE 7 VITROS IPTH2 RESULT OF 44.5 PG/ML (WITHIN THE REFERENCE INTERVAL) VS. THE VITROS IPTH RESULT OF 64.2 PG/ML (ABOVE THE REFERENCE INTERVAL). CORRELATION SAMPLE 11 VITROS IPTH2 RESULT OF 49.9 PG/ML (WITHIN THE REFERENCE INTERVAL) VS. THE VITROS IPTH RESULT OF 72.2 PG/ML (ABOVE THE REFERENCE INTERVAL). CORRELATION SAMPLE 20 VITROS IPTH2 RESULT OF 58.4 PG/ML (WITHIN THE REFERENCE INTERVAL) VS. THE VITROS IPTH RESULT OF 86.6 PG/ML (ABOVE THE REFERENCE INTERVAL). CORRELATION SAMPLE 21 VITROS IPTH2 RESULT OF 62.6 PG/ML (WITHIN THE REFERENCE INTERVAL) VS. THE VITROS IPTH RESULT OF 95.8 PG/ML (ABOVE THE REFERENCE INTERVAL). CORRELATION SAMPLE 22 VITROS IPTH2 RESULT OF 61.9 PG/ML (WITHIN THE REFERENCE INTERVAL)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20048021 ↗
• MalfunctionAug 23, 2024Low Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED VITROS IPTH2 RESULTS HAVE OCCURRED WITH MULTIPLE PATIENT SAMPLES WHEN COMPARING DATA FROM A METHOD COMPARISON STUDY BETWEEN THE VITROS IPTH2 ASSAY AND THE VITROS IPTH ASSAY ON THREE DIFFERENT VITROS XT 7600 INTEGRATED SYSTEMS. THE VITROS IPTH2 REFERENCE INTERVAL: 14.2 - 75.2 PG/ML. THE VITROS IPTH REFERENCE INTERVAL: 7.5 - 53.5 PG/ML. J76000938 CORRELATION SAMPLE 7 VITROS IPTH2 RESULT OF 44.5 PG/ML (WITHIN THE REFERENCE INTERVAL) VS. THE VITROS IPTH RESULT OF 64.2 PG/ML (ABOVE THE REFERENCE INTERVAL). CORRELATION SAMPLE 11 VITROS IPTH2 RESULT OF 49.9 PG/ML (WITHIN THE REFERENCE INTERVAL) VS. THE VITROS IPTH RESULT OF 72.2 PG/ML (ABOVE THE REFERENCE INTERVAL). CORRELATION SAMPLE 20 VITROS IPTH2 RESULT OF 58.4 PG/ML (WITHIN THE REFERENCE INTERVAL) VS. THE VITROS IPTH RESULT OF 86.6 PG/ML (ABOVE THE REFERENCE INTERVAL). CORRELATION SAMPLE 21 VITROS IPTH2 RESULT OF 62.6 PG/ML (WITHIN THE REFERENCE INTERVAL) VS. THE VITROS IPTH RESULT OF 95.8 PG/ML (ABOVE THE REFERENCE INTERVAL). CORRELATION SAMPLE 22 VITROS IPTH2 RESULT OF 61.9 PG/ML (WITHIN THE REFERENCE INTERVAL)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20047879 ↗
• MalfunctionAug 14, 2024Low Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED VITROS INTACT PTH II (IPTH II) RESULTS WERE OBTAINED FROM SEVERAL DIFFERENT PATIENT SAMPLES WHEN TESTED USING VITROS IPTH II REAGENT ON A VITROS XT 7600 INTEGRATED SYSTEM. THE SAMPLES WERE CONSIDERED DISCORDANT WHEN COMPARED TO A NON-VITROS DIASORIN METHOD. PATIENT 1 RESULT OF 48.99 PG/ML VS AN EXPECTED RESULT OF 76.00 PG/ML PATIENT 4 RESULT OF 22.99 PG/ML VS AN EXPECTED RESULT OF 41.00 PG/ML PATIENT 5 RESULT OF 49.19 PG/ML VS AN EXPECTED RESULT OF 83.00 PG/ML PATIENT 7 RESULT OF 25.03 PG/ML VS AN EXPECTED RESULT OF 40.00 PG/ML PATIENT 8 RESULT OF 69.75 PG/ML VS AN EXPECTED RESULT OF 135.00 PG/ML PATIENT 10 RESULT OF 80.19 PG/ML VS AN EXPECTED RESULT OF 151.00 PG/ML BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE LOWER THAN EXPECTED PATIENT SAMPLE RESULTS WERE OBTAINED WHILE PERFORMING AN IPTH II COMPARISON STUDY AND WAS NOT REPORTED FROM THE LABORATORY. THERE WAS NO ALLEGATION OF HARM AS A RESULT OF THE EVENT. THIS REPORT IS NUMBER TWO OF TWO MDRS FOR THIS EVENT. TWO 3500A F

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19982344 ↗
• MalfunctionAug 14, 2024Low Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED VITROS INTACT PTH II (IPTH II) RESULTS WERE OBTAINED FROM SEVERAL DIFFERENT PATIENT SAMPLES WHEN TESTED USING VITROS IPTH II REAGENT ON A VITROS XT 7600 INTEGRATED SYSTEM. THE SAMPLES WERE CONSIDERED DISCORDANT WHEN COMPARED TO A NON-VITROS DIASORIN METHOD. PATIENT 1 RESULT OF 48.99 PG/ML VS AN EXPECTED RESULT OF 76.00 PG/ML PATIENT 4 RESULT OF 22.99 PG/ML VS AN EXPECTED RESULT OF 41.00 PG/ML PATIENT 5 RESULT OF 49.19 PG/ML VS AN EXPECTED RESULT OF 83.00 PG/ML PATIENT 7 RESULT OF 25.03 PG/ML VS AN EXPECTED RESULT OF 40.00 PG/ML PATIENT 8 RESULT OF 69.75 PG/ML VS AN EXPECTED RESULT OF 135.00 PG/ML PATIENT 10 RESULT OF 80.19 PG/ML VS AN EXPECTED RESULT OF 151.00 PG/ML BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE LOWER-THAN-EXPECTED PATIENT SAMPLE RESULTS WERE OBTAINED WHILE PERFORMING AN IPTH II COMPARISON STUDY AND WAS NOT REPORTED FROM THE LABORATORY. THERE WAS NO ALLEGATION OF HARM AS A RESULT OF THE EVENT. THIS REPORT IS NUMBER ONE OF TWO MDRS FOR THIS EVENT. TWO 3500A F

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19982251 ↗
• MalfunctionMar 5, 2024Low Test Results; Low 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 18841780 ↗