VITROS 6802892Recalls & reported problems

Summary

The FDA's MAUDE database contains 155 adverse event reports that list this exact device (DI 10758750006267), received between Nov 15, 2022 and May 11, 2026 — classified as 155 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (115 reports).

1 FDA recall record name this device's identifier, 1 still open.

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 16, 2026.

Recalls naming this device

1. Nov 17, 2022Open, Classified

   Lower than expected iPTH patient and Quality Control (QC) results, reported negatively biased iPTH results- an average -12% shift in patient sample results

   Z-0878-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 155 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 11, 2026High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED VITROS INTACT PTH (IPTH) RESULTS OBTAINED FROM COLLEGE OF AMERICAN PATHOLOGISTS (CAP) PROFICIENCY SAMPLES WHEN TESTED USING A VITROS XT 7600 INTEGRATED SYSTEM. VITROS IPTH LOT 2155: PTH-01 (INITIAL) RESULT OF 518.8 PG/ML VS AN EXPECTED CAP MEAN RESULT OF 360.13 PG/ML PTH-02 (INITIAL) RESULT OF 19.2 PG/ML VS AN EXPECTED CAP MEAN RESULT OF 13.00 PG/ML PTH-03 (INITIAL) RESULT OF 296.4 PG/ML VS AN EXPECTED CAP MEAN RESULT OF 207.23 PG/ML PTH-04 (INITIAL) RESULT OF 1,735 PG/ML VS AN EXPECTED CAP MEAN RESULT OF 1,272.47 PG/ML PTH-05 (INITIAL) RESULT OF 985.7 PG/ML VS AN EXPECTED CAP MEAN RESULT OF 707.56 PG/ML VITROS IPTH LOT 2161: PTH-01 (REPEAT) RESULT OF 491.5 PG/ML VS AN EXPECTED CAP MEAN RESULT OF 360.13 PG/ML PTH-03 (REPEAT) RESULT OF 272.0 PG/ML VS AN EXPECTED CAP MEAN RESULT OF 207.23 PG/ML PTH-04 (REPEAT) RESULT OF 1,696.7 PG/ML VS AN EXPECTED CAP MEAN RESULT OF 1,272.47 PG/ML PTH-05 (REPEAT) RESULT OF 965.5 PG/ML VS AN EXPECTED CAP MEAN RESULT OF 707.56 PG/ML BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION I

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25138853 ↗
• MalfunctionMay 11, 2026High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED VITROS INTACT PTH (IPTH) RESULTS OBTAINED FROM COLLEGE OF AMERICAN PATHOLOGISTS (CAP) PROFICIENCY SAMPLES WHEN TESTED USING A VITROS XT 7600 INTEGRATED SYSTEM. VITROS IPTH LOT 2155: PTH-01 (INITIAL) RESULT OF 518.8 PG/ML VS AN EXPECTED CAP MEAN RESULT OF 360.13 PG/ML PTH-02 (INITIAL) RESULT OF 19.2 PG/ML VS AN EXPECTED CAP MEAN RESULT OF 13.00 PG/ML PTH-03 (INITIAL) RESULT OF 296.4 PG/ML VS AN EXPECTED CAP MEAN RESULT OF 207.23 PG/ML PTH-04 (INITIAL) RESULT OF 1,735 PG/ML VS AN EXPECTED CAP MEAN RESULT OF 1,272.47 PG/ML PTH-05 (INITIAL) RESULT OF 985.7 PG/ML VS AN EXPECTED CAP MEAN RESULT OF 707.56 PG/ML VITROS IPTH LOT 2161: PTH-01 (REPEAT) RESULT OF 491.5 PG/ML VS AN EXPECTED CAP MEAN RESULT OF 360.13 PG/ML PTH-03 (REPEAT) RESULT OF 272.0 PG/ML VS AN EXPECTED CAP MEAN RESULT OF 207.23 PG/ML PTH-04 (REPEAT) RESULT OF 1,696.7 PG/ML VS AN EXPECTED CAP MEAN RESULT OF 1,272.47 PG/ML PTH-05 (REPEAT) RESULT OF 965.5 PG/ML VS AN EXPECTED CAP MEAN RESULT OF 707.56 PG/ML BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION I

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25138818 ↗
• MalfunctionJul 18, 2025High Test Results; High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER-THAN EXPECTED VITROS INTACT PARATHYROID HORMONE (IPTH) RESULTS WERE OBTAINED FROM A SINGLE PATIENT SAMPLE WHEN TESTED ON A VITROS XT 7600 INTEGRATED SYSTEM. THE VITROS IPTH RESULT WAS HIGHER-THAN-EXPECTED WHEN COMPARED TO AN UNKNOWN NON-VITROS METHOD FOR THE SAME PATIENT SAMPLE. PATIENT 1 VITROS IPTH RESULTS OF 10.40 AND 10.25 PMOL/L VERSUS THE EXPECTED RESULT OF 6.70 PMOL/L. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE HIGHER-THAN-EXPECTED VITROS IPTH RESULTS WERE REPORTED FROM THE LABORATORY. THE SURGEON QUESTIONED THE VITROS RESULTS STATING HE DID NOT THINK THE IPTH PATIENT RESULTS SHOULD BE HIGH FOLLOWING A LEFT INFERIOR PARATHYROIDECTOMY ON 18-JUNE-2025. IT IS NOT KNOWN IF ANY CORRECTED REPORT WAS ISSUED. ORTHO HAS NOT BEEN MADE AWARE OF ANY 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 22540378 ↗
• MalfunctionJul 2, 2025Low Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED VITROS IPTH RESULTS HAVE OCCURRED WITH TWO DIFFERENT CORRELATION SAMPLES WHEN COMPARING RESULTS OBTAINED FROM SERUM AND PLASMA SAMPLES COLLECTED FROM THE SAME PATIENTS. THE SAMPLES WERE TESTED ON THE SAME VITROS 5600 INTEGRATED SYSTEM. CORRELATION SAMPLE 4 PLASMA SAMPLE VITROS IPTH RESULT OF 30.9 PG/ML VS. THE CORRELATION SAMPLE 4 SERUM SAMPLE VITROS IPTH RESULT OF 61.3 PG/ML. CORRELATION SAMPLE 14 SERUM SAMPLE VITROS IPTH RESULT OF 32.9 PG/ML VS. THE CORRELATION SAMPLE 14 PLASMA SAMPLE VITROS IPTH RESULT OF 48.7 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 VITROS IPTH RESULTS WERE NOT REPORTED FROM THE LABORATORY AND THERE WAS NO ALLEGATION OF PATIENT HARM. 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 22381715 ↗
• MalfunctionApr 3, 2025High Test Results; High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED INTACT PTH (IPTH) RESULTS WERE OBTAINED WHEN A NON-VITROS, BIORAD, QC FLUID WAS TESTED USING VITROS IPTH LOT 2030 ON A VITROS XT 7600 INTEGRATED SYSTEM. BIORAD LOT 65001 (LEVEL 1) RESULTS OF 33.40, 31.78, 29.45 28.80 AND 28.33 PG/ML VERSUS THE BASELINE MEAN VALUE OF 20.54 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 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) COMPLAINT NUMBER (B)(4) AND REPORTABILITY ASSESSMENT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21761219 ↗
• MalfunctionMar 27, 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 (IPTH) QUALITY CONTROL (QC) RESULT WAS OBTAINED WHEN USING NON-VITROS BIORAD QUALITY CONTROL (QC) FLUID LOT 64990 ON A VITROS XT 7600 INTEGRATED SYSTEM. VITROS IPTH LOT 2070 BIORAD LEVEL 1 QC RESULT OF 31.15 PG/ML VS THE EXPECTED RESULT OF 23.79 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 RESULT WAS OBTAINED WHEN THE CUSTOMER WAS PROCESSING NON-PATIENT FLUIDS. THE CUSTOMER MADE NO INDICATION THAT ANY PATIENT SAMPLE RESULTS HAD BEEN AFFECTED, HOWEVER, THE INVESTIGATION CANNOT CONCLUDE THAT PATIENT SAMPLES WOULD NOT BE AFFECTED IF THE EVENT WERE TO REOCCUR UNDETECTED. THERE HAS BEEN NO ALLEGATION OF HARM AS A RESULT OF THE EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBERS 400247330, 400250793 AND REPORTABILITY ASSESSMENT 609306.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21707022 ↗
• MalfunctionJan 7, 2025High Test Results; High Test Results

  THE CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTIONS CENTER (TSC) TO REPORT HIGHER THAN EXPECTED VITROS INTACT PTH (IPTH) RESULTS OBTAINED ON A VITROS 5600 INTEGRATED SYSTEM. THE HIGHER THAN EXPECTED VITROS IPTH RESULTS WERE OBTAINED WHEN PERFORMING A PATIENT SAMPLE CORRELATION WITH AN ALTERNATE VITROS SITE THAT WAS USING THE VITROS INTACT PTH II (IPTH2) ASSAY. SAMPLE 1 VITROS IPTH 139.3 PG/ML (ABOVE THE REFERENCE INTERVAL) VS. VITROS IPTH2 48.6 PG/ML (WITHIN THE REFERENCE INTERVAL). SAMPLE 2 VITROS IPTH 88.8 PG/ML (ABOVE THE REFERENCE INTERVAL) VS. VITROS IPTH2 49.1 PG/ML (WITHIN THE REFERENCE INTERVAL). SAMPLE 3 VITROS IPTH 114.7 PG/ML (ABOVE THE REFERENCE INTERVAL) VS. VITROS IPTH2 70.9 PG/ML (WITHIN THE REFERENCE INTERVAL). SAMPLE 4 VITROS IPTH 55.2 PG/ML (ABOVE THE REFERENCE INTERVAL) VS. VITROS IPTH2 28.0 PG/ML (WITHIN THE REFERENCE INTERVAL). BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THE RESULTS WERE TO RECUR UNDETECTED. THE HIGHER THAN EXPECTED VITROS IPTH RESULTS WERE OBTAINED AS PART OF A COMPARISON STUDY AND WERE NOT REPORTED FROM THE LABORATORY. THERE WAS NO ALLEGATION OF PATIENT HAR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21096700 ↗
• MalfunctionOct 29, 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 AMERICAN PROFICIENCY INSTITUTE (API) PROFICIENCY SAMPLES WHEN TESTED ON A VITROS XT7600 INTEGRATED SYSTEM IN CONJUNCTION WITH A VITROS IPTH REAGENT. API SAMPLE IAS-11 RESULT OF 184.9 PG/ML VERSUS THE EXPECTED RESULT OF 129.31 PG/ML API SAMPLE IAS-12 RESULT OF 258.8 PG/ML VERSUS THE EXPECTED RESULT OF 185.53 PG/ML API SAMPLE IAS-14 RESULT OF 348.9 PG/ML VERSUS THE EXPECTED RESULT OF 241.86 PG/ML API SAMPLE IAS-15 RESULT OF 110.9 PG/ML VERSUS THE EXPECTED RESULT OF 78.02 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 OBTAINED WERE FROM NON-PATIENT FLUIDS AND WERE REPORTED TO THE PROFICIENCY PROVIDER. 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).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20557886 ↗
• MalfunctionSep 16, 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 A NON-VITROS BIORAD QUALITY CONTROL (QC) FLUID AND PATIENT SAMPLES WHEN TESTED ON TWO DIFFERENT VITROS 5600 INTEGRATED SYSTEM IN CONJUNCTION WITH A VITROS IPTH REAGENT. BIORAD LEVEL 1 LOT 64990 RESULTS OF 28.51, 28.74, 28.87, 28.70, 29.17 AND 28.72 PG/ML VERSUS THE EXPECTED RESULT OF 21.89 PG/ML PATIENT SAMPLE 8 RESULT OF 226.9 PG/ML VERSUS THE EXPECTED RESULT OF 142.2 PG/ML PATIENT SAMPLE 9 RESULT OF 24.91 PG/ML VERSUS THE EXPECTED RESULT OF 19.1 PG/ML BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE HIGHER THAN EXPECTED VITROS IPTH RESULTS WERE OBTAINED FROM A BIORAD QC FLUID AND WHEN PERFORMING A PATIENT SAMPLE CORRELATION EXERCISE AND WERE NOT REPORTED FROM THE LABORATORY. ORTHO HAS NOT BEEN MADE AWARE OF ANY 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 CORRESPONDS TO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20232083 ↗
• MalfunctionSep 16, 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 A NON-VITROS BIORAD QUALITY CONTROL (QC) FLUID AND PATIENT SAMPLES WHEN TESTED ON TWO DIFFERENT VITROS 5600 INTEGRATED SYSTEM IN CONJUNCTION WITH A VITROS IPTH REAGENT. BIORAD LEVEL 1 LOT 64990 RESULTS OF 28.51, 28.74, 28.87, 28.70, 29.17 AND 28.72 PG/ML VERSUS THE EXPECTED RESULT OF 21.89 PG/ML PATIENT SAMPLE (B)(6) RESULT OF 226.9 PG/ML VERSUS THE EXPECTED RESULT OF 142.2 PG/ML PATIENT SAMPLE (B)(6) RESULT OF 24.91 PG/ML VERSUS THE EXPECTED RESULT OF 19.1 PG/ML BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE HIGHER-THAN-EXPECTED VITROS IPTH RESULTS WERE OBTAINED FROM A BIORAD QC FLUID AND WHEN PERFORMING A PATIENT SAMPLE CORRELATION EXERCISE AND WERE NOT REPORTED FROM THE LABORATORY. ORTHO HAS NOT BEEN MADE AWARE OF ANY 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 CORR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20231326 ↗
• MalfunctionAug 22, 2024Low Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED INTACT PTH (IPTH) RESULTS WERE OBTAINED WHEN NON-VITROS (MAS) QC FLUIDS WERE TESTED USING VITROS IPTH LOT 1950 ON A VITROS XT 7600 INTEGRATED SYSTEM. MAS OIM27031A (LEVEL 1) RESULTS OF 18.10, 18.40, 12.55, 17.38, 18.67, 19.45, 17.39, 18.83, 18.67 AND 18.01 PG/ML VERSUS THE CUSTOMER'S ESTIMATED BASELINE MEAN RESULT OF 28 PG/ML MAS OIM27033A (LEVEL 3) RESULT OF 741.09 PG/ML VERSUS THE CUSTOMER'S ESTIMATED BASELINE MEAN RESULT OF 1229 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 LOWER-THAN-EXPECTED VITROS IPTH RESULTS WERE OBTAINED WHEN THE CUSTOMER WAS PROCESSING NON-PATIENT FLUIDS. THERE HAS BEEN NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER THREE OF THREE MDRS FOR THIS EVENT. THREE 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS THREE DEVICES WERE INVOLVED. 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 20030069 ↗
• MalfunctionAug 22, 2024Low Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED INTACT PTH (IPTH) RESULTS WERE OBTAINED WHEN NON-VITROS (MAS) QC FLUIDS WERE TESTED USING VITROS IPTH LOT 1950 ON A VITROS XT 7600 INTEGRATED SYSTEM. MAS OIM27031A (LEVEL 1) RESULTS OF 18.10, 18.40, 12.55, 17.38, 18.67, 19.45, 17.39, 18.83, 18.67 AND 18.01 PG/ML VERSUS THE CUSTOMER'S ESTIMATED BASELINE MEAN RESULT OF 28 PG/ML MAS OIM27033A (LEVEL 3) RESULT OF 741.09 PG/ML VERSUS THE CUSTOMER'S ESTIMATED BASELINE MEAN RESULT OF 1229 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 LOWER-THAN-EXPECTED VITROS IPTH RESULTS WERE OBTAINED WHEN THE CUSTOMER WAS PROCESSING NON-PATIENT FLUIDS. THERE HAS BEEN NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER ONE OF THREE MDRS FOR THIS EVENT. THREE 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS THREE DEVICES WERE INVOLVED. 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 20025319 ↗
• MalfunctionAug 21, 2024Low Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED INTACT PTH (IPTH) RESULTS WERE OBTAINED WHEN NON-VITROS (MAS) QC FLUIDS WERE TESTED USING VITROS IPTH LOT 1950 ON A VITROS XT 7600 INTEGRATED SYSTEM. MAS OIM27031A (LEVEL 1) RESULTS OF 18.10, 18.40, 12.55, 17.38, 18.67, 19.45, 17.39, 18.83, 18.67 AND 18.01 PG/ML VERSUS THE CUSTOMER'S ESTIMATED BASELINE MEAN RESULT OF 28 PG/ML MAS OIM27033A (LEVEL 3) RESULT OF 741.09 PG/ML VERSUS THE CUSTOMER'S ESTIMATED BASELINE MEAN RESULT OF 1229 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 LOWER THAN EXPECTED VITROS IPTH RESULTS WERE OBTAINED WHEN THE CUSTOMER WAS PROCESSING NON-PATIENT FLUIDS. THERE HAS BEEN NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER TWO OF THREE MDRS FOR THIS EVENT. THREE 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS THREE DEVICES WERE INVOLVED. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER (B)(4) AND REPORTABILITY ASSESSMENT 607099.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20014090 ↗
• MalfunctionAug 7, 2024High Test Results; High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED INTACT PTH (IPTH) RESULTS WERE OBTAINED WHEN SAMPLES FROM MULTIPLE PATIENTS WERE TESTED USING VITROS IPTH LOT 1980 ON A VITROS XT 7600 INTEGRATED SYSTEM. THE RESULTS WERE HIGHER THAN EXPECTED WHEN COMPARED TO ROCHE PTH RESULTS FOR THE SAME PATIENT SAMPLES. PATIENT 1, VITROS IPTH RESULT OF 100.57 PG/ML VERSUS THE ROCHE PTH RESULT OF 65.9 PG/ML PATIENT 2, VITROS IPTH RESULTS OF 96.00, 74.44 AND 86.04. PG/ML VERSUS THE ROCHE PTH RESULT OF 63.2 PG/ML PATIENT 3, VITROS IPTH RESULT OF 129.79. PG/ML VERSUS THE ROCHE PTH RESULT OF 79.9 PG/ML PATIENT 4, VITROS IPTH RESULT OF 135.00. PG/ML VERSUS THE ROCHE PTH RESULT OF 93.2 PG/ML PATIENT 5, VITROS IPTH RESULT OF 109.86. PG/ML VERSUS THE ROCHE PTH RESULT OF 69.5 PG/ML PATIENT 6, VITROS IPTH RESULT OF 80.48. PG/ML VERSUS THE ROCHE PTH RESULT OF 52.7 PG/ML BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE HIGHER THAN EXPECTED VITROS IPTH RESULTS WERE REPORTED FROM THE LABORATORY. HOWEVER, NO TREATMENT WAS ALTERED, INITIATED OR STOPPED BAS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19932953 ↗
• MalfunctionAug 7, 2024High 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 (IPTH) RESULT WAS OBTAINED FROM AN AMERICAN PROFICIENCY INSTITUTE (API) PROFICIENCY SAMPLE WHEN TESTED ON A VITROS XT7600 INTEGRATED SYSTEM IN CONJUNCTION WITH A VITROS IPTH REAGENT. API SAMPLE IAS-08 RESULT OF 290.7 PG/ML VERSUS THE EXPECTED RESULT OF 214.82 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 RESULT OBTAINED WAS FROM A NON-PATIENT FLUID AND WAS REPORTED TO THE PROFICIENCY SCHEME PROVIDER. 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 19927430 ↗
• MalfunctionJul 17, 2024Low Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED INTACT PTH (IPTH). RESULTS WERE OBTAINED WHEN NON-VITROS (BIORAD) QC FLUIDS WERE PROCESSED USING VITROS IPTH LOT 1920 AND TWO SAMPLES FROM A SINGLE PATIENT WERE PROCESSED USING VITROS IPTH LOT 1960 ON A VITROS 5600 INTEGRATED SYSTEM. BIORAD LOT 65001 (LEVEL 1), VITROS IPTH LOT 1920 RESULT OF 15.95 PG/ML VERSUS THE CUSTOMER'S ESTIMATED BASELINE MEAN VALUE OF 24 PG/ML BIORAD LOT 65002 (LEVEL 2), VITROS IPTH LOT 1920 RESULT OF 122.32 PG/ML VERSUS THE CUSTOMER'S ESTIMATED BASELINE MEAN VALUE OF 215 PG/ML PATIENT 2, SAMPLE 2, VITROS IPTH LOT 1960 RESULT OF <3.4 PG/ML VERSUS A SIEMENS IPTH RESULT OF 89.3 PG/ML PATIENT 2, SAMPLE 3, VITROS IPTH LOT 1960 RESULT OF <3.4 PG/ML VERSUS A VITROS IPTH II RESULT OF 50.6 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 VITROS IPTH RESULTS WERE REPORTED FROM THE LABORATORY. HOWEVER, THERE HAS BEEN NO INDICATION TREATMENT WAS ALTERED, INITIATED OR STOPPED BASED ON THE REPORTED RESULTS. THERE HAS BEEN NO ALLEGATION OF PA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19765085 ↗
• MalfunctionJul 17, 2024Low Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED INTACT PTH (IPTH) RESULTS WERE OBTAINED WHEN NON-VITROS (BIORAD) QC FLUIDS WERE PROCESSED USING VITROS IPTH LOT 1920 AND TWO SAMPLES FROM A SINGLE PATIENT WERE PROCESSED USING VITROS IPTH LOT 1960 ON A VITROS 5600 INTEGRATED SYSTEM. BIORAD LOT 65001 (LEVEL 1), VITROS IPTH LOT 1920 RESULT OF 15.95 PG/ML VERSUS THE CUSTOMER'S ESTIMATED BASELINE MEAN VALUE OF 24 PG/ML BIORAD LOT 65002 (LEVEL 2), VITROS IPTH LOT 1920 RESULT OF 122.32 PG/ML VERSUS THE CUSTOMER'S ESTIMATED BASELINE MEAN VALUE OF 215 PG/ML PATIENT 2, SAMPLE 2, VITROS IPTH LOT 1960 RESULT OF <3.4 PG/ML VERSUS A SIEMENS IPTH RESULT OF 89.3 PG/ML PATIENT 2, SAMPLE 3, VITROS IPTH LOT 1960 RESULT OF <3.4 PG/ML VERSUS A VITROS IPTH II RESULT OF 50.6 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 VITROS IPTH RESULTS WERE REPORTED FROM THE LABORATORY. HOWEVER, THERE HAS BEEN NO INDICATION TREATMENT WAS ALTERED, INITIATED OR STOPPED BASED ON THE REPORTED RESULTS. THERE HAS BEEN NO ALLEGATION OF PAT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19764768 ↗
• MalfunctionMay 20, 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 ON MULTIPLE PATIENT SAMPLES WHEN TESTED ON A VITROS 5600 INTEGRATED SYSTEM. THE VITROS IPTH RESULTS WERE HIGHER THAN EXPECTED WHEN COMPARED TO RESULTS OBTAINED USING A NON-VITROS ROCHE METHOD FOR THE SAME PATIENT SAMPLES. PATIENT 1 VITROS IPTH LOT 1920: 140 PG/ML VERSUS ROCHE 57.00 PG/ML PATIENT E VITROS IPTH LOT 1920: 102.00, 112.00 PG/ML VERSUS ROCHE 36.00 PG/ML. PATIENT F VITROS IPTH LOT 1920: 90.00, 101.00 PG/ML VERSUS ROCHE 35.00 PG/ML. PATIENT 3 VITROS IPTH LOT UNKNOWN: 99.10 PG/ML VERSUS ROCHE 49.00 PG/ML. PATIENT 4 VITROS IPTH LOT UNKNOWN: 56.10 PG/ML VERSUS ROCHE 31.00 PG/ML. PATIENT 6 VITROS IPTH LOT UNKNOWN: 61.40 PG/ML VERSUS ROCHE 34.00 PG/ML. PATIENT 7 VITROS IPTH LOT UNKNOWN: 63.60 PG/ML VERSUS ROCHE 37.00 PG/ML. PATIENT 9 VITROS IPTH LOT UNKNOWN: 60.40 PG/ML VERSUS ROCHE 36.00 PG/ML. PATIENT 10 VITROS IPTH LOT UNKNOWN: 118.60 PG/ML VERSUS ROCHE 66.00 PG/ML. PATIENT 11 VITROS IPTH LOT UNKNOWN: 57.00 PG/ML VERSUS ROCHE 32.00 PG/ML. PATIENT 12 VITROS IPTH LOT UNKNOWN: 87.50 PG/ML VERSUS ROCHE 56.00 PG/

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19353456 ↗
• MalfunctionMay 20, 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 ON MULTIPLE PATIENT SAMPLES WHEN TESTED ON A VITROS 5600 INTEGRATED SYSTEM. THE VITROS IPTH RESULTS WERE HIGHER THAN EXPECTED WHEN COMPARED TO RESULTS OBTAINED USING A NON-VITROS ROCHE METHOD FOR THE SAME PATIENT SAMPLES. PATIENT 1 VITROS IPTH LOT 1920: 140 PG/ML VERSUS ROCHE 57.00 PG/ML PATIENT E VITROS IPTH LOT 1920: 102.00, 112.00 PG/ML VERSUS ROCHE 36.00 PG/ML. PATIENT F VITROS IPTH LOT 1920: 90.00, 101.00 PG/ML VERSUS ROCHE 35.00 PG/ML. PATIENT 3 VITROS IPTH LOT UNKNOWN: 99.10 PG/ML VERSUS ROCHE 49.00 PG/ML. PATIENT 4 VITROS IPTH LOT UNKNOWN: 56.10 PG/ML VERSUS ROCHE 31.00 PG/ML. PATIENT 6 VITROS IPTH LOT UNKNOWN: 61.40 PG/ML VERSUS ROCHE 34.00 PG/ML. PATIENT 7 VITROS IPTH LOT UNKNOWN: 63.60 PG/ML VERSUS ROCHE 37.00 PG/ML. PATIENT 9 VITROS IPTH LOT UNKNOWN: 60.40 PG/ML VERSUS ROCHE 36.00 PG/ML. PATIENT 10 VITROS IPTH LOT UNKNOWN: 118.60 PG/ML VERSUS ROCHE 66.00 PG/ML. PATIENT 11 VITROS IPTH LOT UNKNOWN: 57.00 PG/ML VERSUS ROCHE 32.00 PG/ML. PATIENT 12 VITROS IPTH LOT UNKNOWN: 87.50 PG/ML VERSUS ROCHE 56.00 PG/

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19353416 ↗
• MalfunctionMay 7, 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 HIGHER THAN EXPECTED VITROS INTACT PTH (IPTH) RESULTS HAVE OCCURRED WITH MULTIPLE PATIENT SAMPLES, TESTED ON A VITRO 5600 INTEGRATED SYSTEM, WHEN COMPARING DATA FROM A METHOD COMPARISON STUDY BETWEEN VITROS IPTH RESULTS AND A NON-VITROS SIEMENS SYSTEM. IN ADDITION, BOTH HIGHER AND LOWER THAN EXPECTED VITROS IPTH RESULTS WERE OBTAINED FROM TWO LEVELS OF NON-VITROS BIORAD SPECIALTY IMMUNOASSAY CONTROLS, LOT 64960 WHEN COMPARED TO THE RESPECTIVE VITROS PEER MEAN. FINALLY, EITHER HIGHER OR LOWER THAN EXPECTED RESULTS WERE OBTAINED FROM A SINGLE LEVEL OF RANDOX IMMUNOASSAY PREMIUM PLUS CONTROL, LOT 2219EC, WHERE THE EXPECTED VALUE WAS UNKNOWN. CORRELATION PATIENT SAMPLE 1 VITROS IPTH SERUM RESULT OF 91.2 PG/ML VS. THE SIEMENS RESULT OF 57.2 PG/ML. CORRELATION PATIENT SAMPLE 2 VITROS IPTH PLASMA RESULT OF 131.6 PG/ML AND THE VITROS IPTH SERUM RESULT OF 155.1 PG/ML VS. THE SIEMENS RESULT OF 69.7 PG/ML. CORRELATION PATIENT SAMPLE 3 VITROS IPTH PLASMA RESULT OF 109.1 PG/ML AND THE VITROS IPTH SERUM RESULT OF 105.2 PG/ML VS. THE SIEMENS RESULT OF 55.8 PG/ML. CORRELATION PATIENT SAMPLE 4 VITR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19260395 ↗
• MalfunctionMay 7, 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 HIGHER THAN EXPECTED VITROS INTACT PTH (IPTH) RESULTS HAVE OCCURRED WITH MULTIPLE PATIENT SAMPLES, TESTED ON A VITRO 5600 INTEGRATED SYSTEM, WHEN COMPARING DATA FROM A METHOD COMPARISON STUDY BETWEEN VITROS IPTH RESULTS AND A NON-VITROS SIEMENS SYSTEM. IN ADDITION, BOTH HIGHER AND LOWER THAN EXPECTED VITROS IPTH RESULTS WERE OBTAINED FROM TWO LEVELS OF NON-VITROS BIORAD SPECIALTY IMMUNOASSAY CONTROLS, LOT 64960 WHEN COMPARED TO THE RESPECTIVE VITROS PEER MEAN. FINALLY, EITHER HIGHER OR LOWER THAN EXPECTED RESULTS WERE OBTAINED FROM A SINGLE LEVEL OF RANDOX IMMUNOASSAY PREMIUM PLUS CONTROL, LOT 2219EC, WHERE THE EXPECTED VALUE WAS UNKNOWN. CORRELATION PATIENT SAMPLE 1 VITROS IPTH SERUM RESULT OF 91.2 PG/ML VS. THE SIEMENS RESULT OF 57.2 PG/ML. CORRELATION PATIENT SAMPLE 2 VITROS IPTH PLASMA RESULT OF 131.6 PG/ML AND THE VITROS IPTH SERUM RESULT OF 155.1 PG/ML VS. THE SIEMENS RESULT OF 69.7 PG/ML. CORRELATION PATIENT SAMPLE 3 VITROS IPTH PLASMA RESULT OF 109.1 PG/ML AND THE VITROS IPTH SERUM RESULT OF 105.2 PG/ML VS. THE SIEMENS RESULT OF 55.8 PG/ML. CORRELATION PATIENT SAMPLE 4 VITR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19260364 ↗
• MalfunctionMay 7, 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 HIGHER THAN EXPECTED VITROS INTACT PTH (IPTH) RESULTS HAVE OCCURRED WITH MULTIPLE PATIENT SAMPLES, TESTED ON A VITRO 5600 INTEGRATED SYSTEM, WHEN COMPARING DATA FROM A METHOD COMPARISON STUDY BETWEEN VITROS IPTH RESULTS AND A NON-VITROS SIEMENS SYSTEM. IN ADDITION, BOTH HIGHER AND LOWER THAN EXPECTED VITROS IPTH RESULTS WERE OBTAINED FROM TWO LEVELS OF NON-VITROS BIORAD SPECIALTY IMMUNOASSAY CONTROLS, LOT 64960 WHEN COMPARED TO THE RESPECTIVE VITROS PEER MEAN. FINALLY, EITHER HIGHER OR LOWER THAN EXPECTED RESULTS WERE OBTAINED FROM A SINGLE LEVEL OF RANDOX IMMUNOASSAY PREMIUM PLUS CONTROL, LOT 2219EC, WHERE THE EXPECTED VALUE WAS UNKNOWN. CORRELATION PATIENT SAMPLE 1 VITROS IPTH SERUM RESULT OF 91.2 PG/ML VS. THE SIEMENS RESULT OF 57.2 PG/ML. CORRELATION PATIENT SAMPLE 2 VITROS IPTH PLASMA RESULT OF 131.6 PG/ML AND THE VITROS IPTH SERUM RESULT OF 155.1 PG/ML VS. THE SIEMENS RESULT OF 69.7 PG/ML. CORRELATION PATIENT SAMPLE 3 VITROS IPTH PLASMA RESULT OF 109.1 PG/ML AND THE VITROS IPTH SERUM RESULT OF 105.2 PG/ML VS. THE SIEMENS RESULT OF 55.8 PG/ML. CORRELATION PATIENT SAMPLE 4 VITR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19260295 ↗
• MalfunctionMay 7, 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 HIGHER THAN EXPECTED VITROS INTACT PTH (IPTH) RESULTS HAVE OCCURRED WITH MULTIPLE PATIENT SAMPLES, TESTED ON A VITRO 5600 INTEGRATED SYSTEM, WHEN COMPARING DATA FROM A METHOD COMPARISON STUDY BETWEEN VITROS IPTH RESULTS AND A NON-VITROS SIEMENS SYSTEM. IN ADDITION, BOTH HIGHER AND LOWER THAN EXPECTED VITROS IPTH RESULTS WERE OBTAINED FROM TWO LEVELS OF NON-VITROS BIORAD SPECIALTY IMMUNOASSAY CONTROLS, LOT 64960 WHEN COMPARED TO THE RESPECTIVE VITROS PEER MEAN. FINALLY, EITHER HIGHER OR LOWER THAN EXPECTED RESULTS WERE OBTAINED FROM A SINGLE LEVEL OF RANDOX IMMUNOASSAY PREMIUM PLUS CONTROL, LOT 2219EC, WHERE THE EXPECTED VALUE WAS UNKNOWN. CORRELATION PATIENT SAMPLE 1 VITROS IPTH SERUM RESULT OF 91.2 PG/ML VS. THE SIEMENS RESULT OF 57.2 PG/ML. CORRELATION PATIENT SAMPLE 2 VITROS IPTH PLASMA RESULT OF 131.6 PG/ML AND THE VITROS IPTH SERUM RESULT OF 155.1 PG/ML VS. THE SIEMENS RESULT OF 69.7 PG/ML. CORRELATION PATIENT SAMPLE 3 VITROS IPTH PLASMA RESULT OF 109.1 PG/ML AND THE VITROS IPTH SERUM RESULT OF 105.2 PG/ML VS. THE SIEMENS RESULT OF 55.8 PG/ML. CORRELATION PATIENT SAMPLE 4 VITR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19260260 ↗
• MalfunctionMay 7, 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 HIGHER THAN EXPECTED VITROS INTACT PTH (IPTH) RESULTS HAVE OCCURRED WITH MULTIPLE PATIENT SAMPLES, TESTED ON A VITRO 5600 INTEGRATED SYSTEM, WHEN COMPARING DATA FROM A METHOD COMPARISON STUDY BETWEEN VITROS IPTH RESULTS AND A NON-VITROS SIEMENS SYSTEM. IN ADDITION, BOTH HIGHER AND LOWER THAN EXPECTED VITROS IPTH RESULTS WERE OBTAINED FROM TWO LEVELS OF NON-VITROS BIORAD SPECIALTY IMMUNOASSAY CONTROLS, LOT 64960 WHEN COMPARED TO THE RESPECTIVE VITROS PEER MEAN. FINALLY, EITHER HIGHER OR LOWER THAN EXPECTED RESULTS WERE OBTAINED FROM A SINGLE LEVEL OF RANDOX IMMUNOASSAY PREMIUM PLUS CONTROL, LOT 2219EC, WHERE THE EXPECTED VALUE WAS UNKNOWN. CORRELATION PATIENT SAMPLE 1 VITROS IPTH SERUM RESULT OF 91.2 PG/ML VS. THE SIEMENS RESULT OF 57.2 PG/ML. CORRELATION PATIENT SAMPLE 2 VITROS IPTH PLASMA RESULT OF 131.6 PG/ML AND THE VITROS IPTH SERUM RESULT OF 155.1 PG/ML VS. THE SIEMENS RESULT OF 69.7 PG/ML. CORRELATION PATIENT SAMPLE 3 VITROS IPTH PLASMA RESULT OF 109.1 PG/ML AND THE VITROS IPTH SERUM RESULT OF 105.2 PG/ML VS. THE SIEMENS RESULT OF 55.8 PG/ML. CORRELATION PATIENT SAMPLE 4 VITR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19260053 ↗
• MalfunctionApr 25, 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 HIGHER AND LOWER THAN EXPECTED VITROS INTACT PTH (IPTH) RESULTS HAVE OCCURRED WITH MULTIPLE PATIENT SAMPLES WHEN COMPARING DATA FROM A METHOD COMPARISON STUDY BETWEEN VITROS IPTH RESULTS AND NON-VITROS ROCHE AND SIEMENS SYSTEMS. CORRELATION SAMPLE 3 VITROS RESULT OF 90.50 PG/ML VS. THE ROCHE RESULT OF 68.74 PG/ML AND THE SIEMENS RESULT OF 69.30 PG/ML CORRELATION SAMPLE 6 VITROS RESULT OF 33.60 PG/ML VS. THE ROCHE RESULT OF 53.81 PG/ML CORRELATION SAMPLE 7 VITROS RESULT OF 40.40 PG/ML VS. THE SIEMENS RESULT OF 30.50 PG/ML CORRELATION SAMPLE 8 VITROS RESULT OF 18.90 PG/ML VS. THE SIEMENS RESULT OF 13.30 PG/ML CORRELATION SAMPLE12 VITROS RESULT OF 30.80 PG/ML VS. THE SIEMENS RESULT OF 19.10 PG/ML CORRELATION SAMPLE 14 VITROS RESULT OF 44.10 PG/ML VS. THE ROCHE RESULT OF 27.50 PG/ML AND THE SIEMENS RESULT OF 32.40 PG/ML CORRELATION SAMPLE 16 VITROS RESULT OF 58.60 PG/ML VS. THE ROCHE RESULT OF 43.37 PG/ML CORRELATION SAMPLE 17 VITROS RESULT OF 50.60 PG/ML VS. THE SIEMENS RESULT OF 33.00 PG/ML CORRELATION SAMPLE 18 VITROS RESULT OF 51.10 PG/ML VS. THE ROCHE RESULT OF 32.94 PG/ML AND THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19182460 ↗