VITROS 1912997Recalls & reported problems

Summary

The FDA's MAUDE database contains 201 adverse event reports that list this exact device (DI 10758750000227), received between Nov 21, 2022 and Sep 22, 2026 — classified as 201 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (146 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 25 most recent of 201 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2026Low Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50859449 ↗
• MalfunctionMay 26, 2026Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED THYROID STIMULATING HORMONE (TSH) RESULTS OBTAINED FROM AMERICAN PROFICIENCY INSTITUTE (API) PROFICIENCY SAMPLE FLUIDS USING VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT LOT 7540 ON A VITROS 5600 INTEGRATED SYSTEM. API SAMPLE CH-01 VITROS TSH RESULT OF 1.82 UIU/ML VS AN EXPECTED RESULT OF 3.423 UIU/ML API SAMPLE CH-02 VITROS TSH RESULT OF <0.02 UIU/ML VS AN EXPECTED RESULT OF 0.062 UIU/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 TSH RESULTS WERE FROM NON-PATIENT FLUIDS. THERE WERE NO ALLEGATIONS 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 25283754 ↗
• MalfunctionApr 16, 2026Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT DISCORDANT, LOWER THAN EXPECTED TSH RESULTS WERE OBTAINED WHEN SAMPLES FROM TWO DIFFERENT PATIENTS WERE TESTED USING VITROS TSH LOT 7601 AND VITROS TSH LOT 7610 ON A VITROS 5600 INTEGRATED SYSTEM. THE RESULTS WERE DISCORDANT WHEN COMPARED TO ROCHE TSH RESULTS FOR THE SAME PATIENT SAMPLES. PATIENT 1, VITROS TSH LOT 7601 RESULT OF <0.015 MIU/L (HYPERTHYROID) VERSUS A ROCHE TSH RESULT OF 1.39 MIU/L (EUTHYROID) PATIENT 2, VITROS TSH LOT 7610 RESULT OF 0.063 MIU/L (HYPERTHYROID) VERSUS A ROCHE TSH RESULT OF 1.88 MIU/L (EUTHYROID) 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 TSH RESULTS WERE REPORTED FROM THE LABORATORY, HOWEVER, CORRECTED REPORTS DOCUMENTING THE ROCHE TSH RESULTS WERE LATER ISSUED. NO TREATMENT WAS ALTERED, INITIATED OR STOPPED DUE TO THE INITIALLY REPORTED VITROS TSH RESULTS. THERE HAS BEEN 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 TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24905163 ↗
• MalfunctionApr 16, 2026Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT DISCORDANT, LOWER THAN EXPECTED TSH RESULTS WERE OBTAINED WHEN SAMPLES FROM TWO DIFFERENT PATIENTS WERE TESTED USING VITROS TSH LOT 7601 AND VITROS TSH LOT 7610 ON A VITROS 5600 INTEGRATED SYSTEM. THE RESULTS WERE DISCORDANT WHEN COMPARED TO ROCHE TSH RESULTS FOR THE SAME PATIENT SAMPLES. PATIENT 1, VITROS TSH LOT 7601 RESULT OF <0.015 MIU/L (HYPERTHYROID) VERSUS A ROCHE TSH RESULT OF 1.39 MIU/L (EUTHYROID) PATIENT 2, VITROS TSH LOT 7610 RESULT OF 0.063 MIU/L (HYPERTHYROID) VERSUS A ROCHE TSH RESULT OF 1.88 MIU/L (EUTHYROID) 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 TSH RESULTS WERE REPORTED FROM THE LABORATORY, HOWEVER, CORRECTED REPORTS DOCUMENTING THE ROCHE TSH RESULTS WERE LATER ISSUED. NO TREATMENT WAS ALTERED, INITIATED OR STOPPED DUE TO THE INITIALLY REPORTED VITROS TSH RESULTS. THERE HAS BEEN 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 TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24899655 ↗
• MalfunctionApr 6, 2026High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED THYROID STIMULATING HORMONE (TSH) RESULTS WERE OBTAINED FROM A NON-VITROS MAS QUALITY CONTROL FLUID PROCESSED USING VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT LOT 7520 ON A VITROS 5600 INTEGRATED SYSTEM. MAS LOT OIM2810 LEVEL 1 RESULTS OF 0.215, 0.228, 0.211 AND 0.205 MIU/L VS THE EXPECTED RESULT OF 0.131 MIU/L 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 TSH RESULTS WERE FROM A NON-PATIENT FLUID. THE CUSTOMER STATED THAT NO PATIENT SAMPLE RESULTS HAD BEEN AFFECTED OR QUESTIONED. 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 24794626 ↗
• MalfunctionMar 25, 2026Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED VITROS TSH RESULTS WERE OBTAINED FROM SAMPLES FROM FIVE DIFFERENT PATIENTS WHEN TESTED USING VITROS IMMUNODIAGNOSTICS PRODUCTS TSH REAGENT, LOT 7572, ON A VITROS XT 7600 INTEGRATED SYSTEM. THE RESULTS WERE CONSIDERED LOWER THAN EXPECTED WHEN COMPARED TO NON-VITROS ROCHE METHOD RESULTS USING THE SAME SAMPLES. PATIENT 1 SAMPLE 1 VITROS TSH RESULTS OF 0.2 UIU/ML (HYPERTHYROID) VS EXPECTED NON-VITROS RESULT OF 1.3 UIU/ML (EUTHYROID) PATIENT 2 SAMPLE 1 VITROS TSH RESULTS OF <0.2 UIU/ML (HYPERTHYROID) VS EXPECTED NON-VITROS RESULT OF 0.70 UIU/ML (EUTHYROID) PATIENT 3 SAMPLE 1 VITROS TSH RESULTS OF 0.18 UIU/ML (HYPERTHYROID) VS EXPECTED NON-VITROS RESULT OF 1.85 UIU/ML (EUTHYROID) PATIENT 4 SAMPLE 1 VITROS TSH RESULTS OF 0.49 UIU/ML (EUTHYROID) VS EXPECTED NON-VITROS RESULT OF 1.53 UIU/ML (EUTHYROID) PATIENT 5 SAMPLE 1 VITROS TSH RESULTS OF 0.28 UIU/ML (HYPERTHYROID) VS EXPECTED NON-VITROS RESULT OF 2.99 UIU/ML (EUTHYROID) BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE LOWER-THAN-E

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24687212 ↗
• MalfunctionMar 25, 2026Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED VITROS TSH RESULTS WERE OBTAINED FROM SAMPLES FROM FIVE DIFFERENT PATIENTS WHEN TESTED USING VITROS IMMUNODIAGNOSTICS PRODUCTS TSH REAGENT, LOT 7572, ON A VITROS XT 7600 INTEGRATED SYSTEM. THE RESULTS WERE CONSIDERED LOWER THAN EXPECTED WHEN COMPARED TO NON-VITROS ROCHE METHOD RESULTS USING THE SAME SAMPLES. PATIENT 1 SAMPLE 1 VITROS TSH RESULTS OF 0.2 UIU/ML (HYPERTHYROID) VS EXPECTED NON-VITROS RESULT OF 1.3 UIU/ML (EUTHYROID) PATIENT 2 SAMPLE 1 VITROS TSH RESULTS OF <0.2 UIU/ML (HYPERTHYROID) VS EXPECTED NON-VITROS RESULT OF 0.70 UIU/ML (EUTHYROID) PATIENT 3 SAMPLE 1 VITROS TSH RESULTS OF 0.18 UIU/ML (HYPERTHYROID) VS EXPECTED NON-VITROS RESULT OF 1.85 UIU/ML (EUTHYROID) PATIENT 4 SAMPLE 1 VITROS TSH RESULTS OF 0.49 UIU/ML (EUTHYROID) VS EXPECTED NON-VITROS RESULT OF 1.53 UIU/ML (EUTHYROID) PATIENT 5 SAMPLE 1 VITROS TSH RESULTS OF 0.28 UIU/ML (HYPERTHYROID) VS EXPECTED NON-VITROS RESULT OF 2.99 UIU/ML (EUTHYROID) BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE LOWER THAN E

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24687208 ↗
• MalfunctionMar 25, 2026Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED VITROS TSH RESULTS WERE OBTAINED FROM SAMPLES FROM FIVE DIFFERENT PATIENTS WHEN TESTED USING VITROS IMMUNODIAGNOSTICS PRODUCTS TSH REAGENT, LOT 7572, ON A VITROS XT 7600 INTEGRATED SYSTEM. THE RESULTS WERE CONSIDERED LOWER THAN EXPECTED WHEN COMPARED TO NON-VITROS ROCHE METHOD RESULTS USING THE SAME SAMPLES. PATIENT 1 SAMPLE 1 VITROS TSH RESULTS OF 0.2 UIU/ML (HYPERTHYROID) VS EXPECTED NON-VITROS RESULT OF 1.3 UIU/ML (EUTHYROID) PATIENT 2 SAMPLE 1 VITROS TSH RESULTS OF <0.2 UIU/ML (HYPERTHYROID) VS EXPECTED NON-VITROS RESULT OF 0.70 UIU/ML (EUTHYROID) PATIENT 3 SAMPLE 1 VITROS TSH RESULTS OF 0.18 UIU/ML (HYPERTHYROID) VS EXPECTED NON-VITROS RESULT OF 1.85 UIU/ML (EUTHYROID) PATIENT 4 SAMPLE 1 VITROS TSH RESULTS OF 0.49 UIU/ML (EUTHYROID) VS EXPECTED NON-VITROS RESULT OF 1.53 UIU/ML (EUTHYROID) PATIENT 5 SAMPLE 1 VITROS TSH RESULTS OF 0.28 UIU/ML (HYPERTHYROID) VS EXPECTED NON-VITROS RESULT OF 2.99 UIU/ML (EUTHYROID) BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE LOWER THAN E

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24687189 ↗
• MalfunctionMar 25, 2026Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED VITROS TSH RESULTS WERE OBTAINED FROM SAMPLES FROM FIVE DIFFERENT PATIENTS WHEN TESTED USING VITROS IMMUNODIAGNOSTICS PRODUCTS TSH REAGENT, LOT 7572, ON A VITROS XT 7600 INTEGRATED SYSTEM. THE RESULTS WERE CONSIDERED LOWER THAN EXPECTED WHEN COMPARED TO NON-VITROS ROCHE METHOD RESULTS USING THE SAME SAMPLES. PATIENT 1 SAMPLE 1 VITROS TSH RESULTS OF 0.2 UIU/ML (HYPERTHYROID) VS EXPECTED NON-VITROS RESULT OF 1.3 UIU/ML (EUTHYROID) PATIENT 2 SAMPLE 1 VITROS TSH RESULTS OF <0.2 UIU/ML (HYPERTHYROID) VS EXPECTED NON-VITROS RESULT OF 0.70 UIU/ML (EUTHYROID) PATIENT 3 SAMPLE 1 VITROS TSH RESULTS OF 0.18 UIU/ML (HYPERTHYROID) VS EXPECTED NON-VITROS RESULT OF 1.85 UIU/ML (EUTHYROID) PATIENT 4 SAMPLE 1 VITROS TSH RESULTS OF 0.49 UIU/ML (EUTHYROID) VS EXPECTED NON-VITROS RESULT OF 1.53 UIU/ML (EUTHYROID) PATIENT 5 SAMPLE 1 VITROS TSH RESULTS OF 0.28 UIU/ML (HYPERTHYROID) VS EXPECTED NON-VITROS RESULT OF 2.99 UIU/ML (EUTHYROID) BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE LOWER-THAN-E

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24687186 ↗
• MalfunctionMar 25, 2026Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED VITROS TSH RESULTS WERE OBTAINED FROM SAMPLES FROM FIVE DIFFERENT PATIENTS WHEN TESTED USING VITROS IMMUNODIAGNOSTICS PRODUCTS TSH REAGENT, LOT 7572, ON A VITROS XT 7600 INTEGRATED SYSTEM. THE RESULTS WERE CONSIDERED LOWER THAN EXPECTED WHEN COMPARED TO NON-VITROS ROCHE METHOD RESULTS USING THE SAME SAMPLES. PATIENT 1 SAMPLE 1 VITROS TSH RESULTS OF 0.2 UIU/ML (HYPERTHYROID) VS EXPECTED NON-VITROS RESULT OF 1.3 UIU/ML (EUTHYROID) PATIENT 2 SAMPLE 1 VITROS TSH RESULTS OF <0.2 UIU/ML (HYPERTHYROID) VS EXPECTED NON-VITROS RESULT OF 0.70 UIU/ML (EUTHYROID) PATIENT 3 SAMPLE 1 VITROS TSH RESULTS OF 0.18 UIU/ML (HYPERTHYROID) VS EXPECTED NON-VITROS RESULT OF 1.85 UIU/ML (EUTHYROID) PATIENT 4 SAMPLE 1 VITROS TSH RESULTS OF 0.49 UIU/ML (EUTHYROID) VS EXPECTED NON-VITROS RESULT OF 1.53 UIU/ML (EUTHYROID) PATIENT 5 SAMPLE 1 VITROS TSH RESULTS OF 0.28 UIU/ML (HYPERTHYROID) VS EXPECTED NON-VITROS RESULT OF 2.99 UIU/ML (EUTHYROID) BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE LOWER-THAN-E

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24687145 ↗
• MalfunctionMar 13, 2026High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED FT4 RESULTS, WERE OBTAINED DURING A PATIENT CORRELATION TESTING USING VITROS IMMUNODIAGNOSTICS PRODUCTS FREE T4 (FT4) REAGENTS ON A VITROS 5600 INTEGRATED SYSTEM. THE RESULTS WERE CONSIDERED DISCORDANT WHEN COMPARED TO REPEAT TESTING PERFORMED USING A NON-VITROS BECKMAN METHOD. VITROS 5600 INTEGRATED SYSTEM: S/N (B)(6): PATIENT 1, VITROS FT4 LOT 6100 RESULT OF 18.3 UIU/ML (EUTHYROID) VS. THE EXPECTED RESULT OF 6.9 UIU/ML (HYPOTHYROID) PATIENT 6, VITROS FT4 LOT 6100 RESULT OF 40.6 UIU/ML (HYPERTHYROID) VS. THE EXPECTED RESULT OF <5.2 UIU/ML (HYPOTHYROID) 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 FT4 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 CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER (B)(4) AND REPORT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24589543 ↗
• MalfunctionMar 12, 2026High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED FT4 RESULTS, WERE OBTAINED DURING A PATIENT CORRELATION TESTING USING VITROS IMMUNODIAGNOSTICS PRODUCTS FREE T4 (FT4) REAGENTS ON A VITROS 5600 INTEGRATED SYSTEM. THE RESULTS WERE CONSIDERED DISCORDANT WHEN COMPARED TO REPEAT TESTING PERFORMED USING A NON-VITROS BECKMAN METHOD. VITROS 5600 INTEGRATED SYSTEM: S/N (B)(6): PATIENT 1, VITROS FT4 LOT 6100 RESULT OF 18.3 UIU/ML (EUTHYROID) VS. THE EXPECTED RESULT OF 6.9 UIU/ML (HYPOTHYROID) PATIENT 6, VITROS FT4 LOT 6100 RESULT OF 40.6 UIU/ML (HYPERTHYROID) VS. THE EXPECTED RESULT OF <5.2 UIU/ML (HYPOTHYROID) 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 FT4 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 CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER (B)(4) AND REPORT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24583152 ↗
• MalfunctionMar 3, 2026Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A LOWER THAN EXPECTED TSH A SINGLE PATIENT SAMPLE RESULT WAS OBTAINED WHEN TESTED USING THE VITROS IMMUNODIAGNOSTICS PRODUCTS TSH REAGENT, LOT 7590, ON A VITROS XT 7600 INTEGRATED SYSTEM. THIS PATIENT SAMPLE RESULT WAS CONSIDERED DISCORDANT WHEN COMPARED WITH REPEAT TESTING OF THE SAME SAMPLE. VITROS TSH PATIENT RESULT OF <0.015 MIU/L (HYPERTHYROID CLASSIFICATION) VS. THE EXPECTED RESULT OF 0.242 MIU/L (HYPERTHYROID CLASSIFICATION) THE LOWER THAN EXPECTED VITROS TSH RESULT OF <0.015 MIU/L WAS NOT REPORTED FROM THE LABORATORY. 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 613627.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24500220 ↗
• MalfunctionFeb 2, 2026Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT DISCORDANT, LOWER THAN EXPECTED TSH RESULTS WERE OBTAINED WHEN MULTIPLE PATIENT SAMPLES WERE TESTED USING VITROS TSH LOT 7450 AND LOT 7470 ON A VITROS XT 7600 INTEGRATED SYSTEM. THE VITROS TSH RESULTS WERE DISCORDANT WHEN COMPARED TO VITROS TSH3 RESULTS FOR THE SAMPLES. SAMPLE P4, VITROS TSH LOT 7450 RESULT OF 0.241 MIU/L (HYPERTHYROID) VERSUS THE VITROS TSH3 LOT 0890 RESULT OF 0.468 UIU/ML (EUTHYROID) SAMPLE P55, VITROS TSH LOT 7450 RESULT OF 0.280 MIU/L (HYPERTHYROID) VERSUS THE VITROS TSH3 LOT 0890 RESULT OF 0.455 UIU/ML (EUTHYROID) SAMPLE P82, VITROS TSH LOT 7450 RESULT OF 0.395 MIU/L (HYPERTHYROID) VERSUS THE VITROS TSH3 LOT 0890 RESULT OF 0.668 UIU/ML (EUTHYROID) SAMPLE P116, VITROS TSH LOT 7450 RESULT OF <0.015 MIU/L (HYPERTHYROID) VERSUS THE VITROS TSH3 LOT 0890 RESULT OF 1.962 UIU/ML (EUTHYROID) SAMPLE P136, VITROS TSH LOT 7450 RESULT OF 0.156 MIU/L (HYPERTHYROID) VERSUS THE VITROS TSH3 LOT 0890 RESULT OF 1.848 UIU/ML (EUTHYROID) SAMPLE P155, VITROS TSH LOT 7450 RESULT OF <0.015 MIU/L (HYPERTHYROID) VERSUS THE VITROS TSH3 LOT 0890 RESULT OF 3.354 UIU/ML (EUTHYROID) SAMPLE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24236192 ↗
• MalfunctionJan 30, 2026Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT DISCORDANT, LOWER THAN EXPECTED TSH RESULTS WERE OBTAINED WHEN MULTIPLE PATIENT SAMPLES WERE TESTED USING VITROS TSH LOT 7450 AND LOT 7470 ON A VITROS XT 7600 INTEGRATED SYSTEM. THE VITROS TSH RESULTS WERE DISCORDANT WHEN COMPARED TO VITROS TSH3 RESULTS FOR THE SAMPLES. SAMPLE P4, VITROS TSH LOT 7450 RESULT OF 0.241 MIU/L (HYPERTHYROID) VERSUS THE VITROS TSH3 LOT 0890 RESULT OF 0.468 UIU/ML (EUTHYROID) SAMPLE P55, VITROS TSH LOT 7450 RESULT OF 0.280 MIU/L (HYPERTHYROID) VERSUS THE VITROS TSH3 LOT 0890 RESULT OF 0.455 UIU/ML (EUTHYROID) SAMPLE P82, VITROS TSH LOT 7450 RESULT OF 0.395 MIU/L (HYPERTHYROID) VERSUS THE VITROS TSH3 LOT 0890 RESULT OF 0.668 UIU/ML (EUTHYROID) SAMPLE P116, VITROS TSH LOT 7450 RESULT OF <0.015 MIU/L (HYPERTHYROID) VERSUS THE VITROS TSH3 LOT 0890 RESULT OF 1.962 UIU/ML (EUTHYROID) SAMPLE P136, VITROS TSH LOT 7450 RESULT OF 0.156 MIU/L (HYPERTHYROID) VERSUS THE VITROS TSH3 LOT 0890 RESULT OF 1.848 UIU/ML (EUTHYROID) SAMPLE P155, VITROS TSH LOT 7450 RESULT OF <0.015 MIU/L (HYPERTHYROID) VERSUS THE VITROS TSH3 LOT 0890 RESULT OF 3.354 UIU/ML (EUTHYROID) SAMPLE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24223967 ↗
• MalfunctionJan 30, 2026Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT DISCORDANT, LOWER THAN EXPECTED TSH RESULTS WERE OBTAINED WHEN MULTIPLE PATIENT SAMPLES WERE TESTED USING VITROS TSH LOT 7450 AND LOT 7470 ON A VITROS XT 7600 INTEGRATED SYSTEM. THE VITROS TSH RESULTS WERE DISCORDANT WHEN COMPARED TO VITROS TSH3 RESULTS FOR THE SAMPLES. SAMPLE P4, VITROS TSH LOT 7450 RESULT OF 0.241 MIU/L (HYPERTHYROID) VERSUS THE VITROS TSH3 LOT 0890 RESULT OF 0.468 UIU/ML (EUTHYROID) SAMPLE P55, VITROS TSH LOT 7450 RESULT OF 0.280 MIU/L (HYPERTHYROID) VERSUS THE VITROS TSH3 LOT 0890 RESULT OF 0.455 UIU/ML (EUTHYROID) SAMPLE P82, VITROS TSH LOT 7450 RESULT OF 0.395 MIU/L (HYPERTHYROID) VERSUS THE VITROS TSH3 LOT 0890 RESULT OF 0.668 UIU/ML (EUTHYROID) SAMPLE P116, VITROS TSH LOT 7450 RESULT OF <0.015 MIU/L (HYPERTHYROID) VERSUS THE VITROS TSH3 LOT 0890 RESULT OF 1.962 UIU/ML (EUTHYROID) SAMPLE P136, VITROS TSH LOT 7450 RESULT OF 0.156 MIU/L (HYPERTHYROID) VERSUS THE VITROS TSH3 LOT 0890 RESULT OF 1.848 UIU/ML (EUTHYROID) SAMPLE P155, VITROS TSH LOT 7450 RESULT OF <0.015 MIU/L (HYPERTHYROID) VERSUS THE VITROS TSH3 LOT 0890 RESULT OF 3.354 UIU/ML (EUTHYROID) SAMPLE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24223952 ↗
• MalfunctionJan 30, 2026Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT DISCORDANT, LOWER THAN EXPECTED TSH RESULTS WERE OBTAINED WHEN MULTIPLE PATIENT SAMPLES WERE TESTED USING VITROS TSH LOT 7450 AND LOT 7470 ON A VITROS XT 7600 INTEGRATED SYSTEM. THE VITROS TSH RESULTS WERE DISCORDANT WHEN COMPARED TO VITROS TSH3 RESULTS FOR THE SAMPLES. SAMPLE P4, VITROS TSH LOT 7450 RESULT OF 0.241 MIU/L (HYPERTHYROID) VERSUS THE VITROS TSH3 LOT 0890 RESULT OF 0.468 UIU/ML (EUTHYROID) SAMPLE P55, VITROS TSH LOT 7450 RESULT OF 0.280 MIU/L (HYPERTHYROID) VERSUS THE VITROS TSH3 LOT 0890 RESULT OF 0.455 UIU/ML (EUTHYROID) SAMPLE P82, VITROS TSH LOT 7450 RESULT OF 0.395 MIU/L (HYPERTHYROID) VERSUS THE VITROS TSH3 LOT 0890 RESULT OF 0.668 UIU/ML (EUTHYROID) SAMPLE P116, VITROS TSH LOT 7450 RESULT OF <0.015 MIU/L (HYPERTHYROID) VERSUS THE VITROS TSH3 LOT 0890 RESULT OF 1.962 UIU/ML (EUTHYROID) SAMPLE P136, VITROS TSH LOT 7450 RESULT OF 0.156 MIU/L (HYPERTHYROID) VERSUS THE VITROS TSH3 LOT 0890 RESULT OF 1.848 UIU/ML (EUTHYROID) SAMPLE P155, VITROS TSH LOT 7450 RESULT OF <0.015 MIU/L (HYPERTHYROID) VERSUS THE VITROS TSH3 LOT 0890 RESULT OF 3.354 UIU/ML (EUTHYROID) SAMPLE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24223940 ↗
• MalfunctionJan 30, 2026Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT DISCORDANT, LOWER THAN EXPECTED TSH RESULTS WERE OBTAINED WHEN MULTIPLE PATIENT SAMPLES WERE TESTED USING VITROS TSH LOT 7450 AND LOT 7470 ON A VITROS XT 7600 INTEGRATED SYSTEM. THE VITROS TSH RESULTS WERE DISCORDANT WHEN COMPARED TO VITROS TSH3 RESULTS FOR THE SAMPLES. SAMPLE P4, VITROS TSH LOT 7450 RESULT OF 0.241 MIU/L (HYPERTHYROID) VERSUS THE VITROS TSH3 LOT 0890 RESULT OF 0.468 UIU/ML (EUTHYROID) SAMPLE P55, VITROS TSH LOT 7450 RESULT OF 0.280 MIU/L (HYPERTHYROID) VERSUS THE VITROS TSH3 LOT 0890 RESULT OF 0.455 UIU/ML (EUTHYROID) SAMPLE P82, VITROS TSH LOT 7450 RESULT OF 0.395 MIU/L (HYPERTHYROID) VERSUS THE VITROS TSH3 LOT 0890 RESULT OF 0.668 UIU/ML (EUTHYROID) SAMPLE P116, VITROS TSH LOT 7450 RESULT OF <0.015 MIU/L (HYPERTHYROID) VERSUS THE VITROS TSH3 LOT 0890 RESULT OF 1.962 UIU/ML (EUTHYROID) SAMPLE P136, VITROS TSH LOT 7450 RESULT OF 0.156 MIU/L (HYPERTHYROID) VERSUS THE VITROS TSH3 LOT 0890 RESULT OF 1.848 UIU/ML (EUTHYROID) SAMPLE P155, VITROS TSH LOT 7450 RESULT OF <0.015 MIU/L (HYPERTHYROID) VERSUS THE VITROS TSH3 LOT 0890 RESULT OF 3.354 UIU/ML (EUTHYROID) SAMPLE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24223923 ↗
• MalfunctionJan 30, 2026Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT DISCORDANT, LOWER THAN EXPECTED TSH RESULTS WERE OBTAINED WHEN MULTIPLE PATIENT SAMPLES WERE TESTED USING VITROS TSH LOT 7450 AND LOT 7470 ON A VITROS XT 7600 INTEGRATED SYSTEM. THE VITROS TSH RESULTS WERE DISCORDANT WHEN COMPARED TO VITROS TSH3 RESULTS FOR THE SAMPLES. SAMPLE P4, VITROS TSH LOT 7450 RESULT OF 0.241 MIU/L (HYPERTHYROID) VERSUS THE VITROS TSH3 LOT 0890 RESULT OF 0.468 UIU/ML (EUTHYROID) SAMPLE P55, VITROS TSH LOT 7450 RESULT OF 0.280 MIU/L (HYPERTHYROID) VERSUS THE VITROS TSH3 LOT 0890 RESULT OF 0.455 UIU/ML (EUTHYROID) SAMPLE P82, VITROS TSH LOT 7450 RESULT OF 0.395 MIU/L (HYPERTHYROID) VERSUS THE VITROS TSH3 LOT 0890 RESULT OF 0.668 UIU/ML (EUTHYROID) SAMPLE P116, VITROS TSH LOT 7450 RESULT OF <0.015 MIU/L (HYPERTHYROID) VERSUS THE VITROS TSH3 LOT 0890 RESULT OF 1.962 UIU/ML (EUTHYROID) SAMPLE P136, VITROS TSH LOT 7450 RESULT OF 0.156 MIU/L (HYPERTHYROID) VERSUS THE VITROS TSH3 LOT 0890 RESULT OF 1.848 UIU/ML (EUTHYROID) SAMPLE P155, VITROS TSH LOT 7450 RESULT OF <0.015 MIU/L (HYPERTHYROID) VERSUS THE VITROS TSH3 LOT 0890 RESULT OF 3.354 UIU/ML (EUTHYROID) SAMPLE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24223892 ↗
• MalfunctionJan 30, 2026Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT DISCORDANT, LOWER THAN EXPECTED TSH RESULTS WERE OBTAINED WHEN MULTIPLE PATIENT SAMPLES WERE TESTED USING VITROS TSH LOT 7450 AND LOT 7470 ON A VITROS XT 7600 INTEGRATED SYSTEM. THE VITROS TSH RESULTS WERE DISCORDANT WHEN COMPARED TO VITROS TSH3 RESULTS FOR THE SAMPLES. SAMPLE P4, VITROS TSH LOT 7450 RESULT OF 0.241 MIU/L (HYPERTHYROID) VERSUS THE VITROS TSH3 LOT 0890 RESULT OF 0.468 UIU/ML (EUTHYROID) SAMPLE P55, VITROS TSH LOT 7450 RESULT OF 0.280 MIU/L (HYPERTHYROID) VERSUS THE VITROS TSH3 LOT 0890 RESULT OF 0.455 UIU/ML (EUTHYROID) SAMPLE P82, VITROS TSH LOT 7450 RESULT OF 0.395 MIU/L (HYPERTHYROID) VERSUS THE VITROS TSH3 LOT 0890 RESULT OF 0.668 UIU/ML (EUTHYROID) SAMPLE P116, VITROS TSH LOT 7450 RESULT OF <0.015 MIU/L (HYPERTHYROID) VERSUS THE VITROS TSH3 LOT 0890 RESULT OF 1.962 UIU/ML (EUTHYROID) SAMPLE P136, VITROS TSH LOT 7450 RESULT OF 0.156 MIU/L (HYPERTHYROID) VERSUS THE VITROS TSH3 LOT 0890 RESULT OF 1.848 UIU/ML (EUTHYROID) SAMPLE P155, VITROS TSH LOT 7450 RESULT OF <0.015 MIU/L (HYPERTHYROID) VERSUS THE VITROS TSH3 LOT 0890 RESULT OF 3.354 UIU/ML (EUTHYROID) SAMPLE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24223879 ↗
• MalfunctionJan 30, 2026Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT DISCORDANT, LOWER THAN EXPECTED TSH RESULTS WERE OBTAINED WHEN MULTIPLE PATIENT SAMPLES WERE TESTED USING VITROS TSH LOT 7450 AND LOT 7470 ON A VITROS XT 7600 INTEGRATED SYSTEM. THE VITROS TSH RESULTS WERE DISCORDANT WHEN COMPARED TO VITROS TSH3 RESULTS FOR THE SAMPLES. SAMPLE P4, VITROS TSH LOT 7450 RESULT OF 0.241 MIU/L (HYPERTHYROID) VERSUS THE VITROS TSH3 LOT 0890 RESULT OF 0.468 UIU/ML (EUTHYROID) SAMPLE P55, VITROS TSH LOT 7450 RESULT OF 0.280 MIU/L (HYPERTHYROID) VERSUS THE VITROS TSH3 LOT 0890 RESULT OF 0.455 UIU/ML (EUTHYROID) SAMPLE P82, VITROS TSH LOT 7450 RESULT OF 0.395 MIU/L (HYPERTHYROID) VERSUS THE VITROS TSH3 LOT 0890 RESULT OF 0.668 UIU/ML (EUTHYROID) SAMPLE P116, VITROS TSH LOT 7450 RESULT OF <0.015 MIU/L (HYPERTHYROID) VERSUS THE VITROS TSH3 LOT 0890 RESULT OF 1.962 UIU/ML (EUTHYROID) SAMPLE P136, VITROS TSH LOT 7450 RESULT OF 0.156 MIU/L (HYPERTHYROID) VERSUS THE VITROS TSH3 LOT 0890 RESULT OF 1.848 UIU/ML (EUTHYROID) SAMPLE P155, VITROS TSH LOT 7450 RESULT OF <0.015 MIU/L (HYPERTHYROID) VERSUS THE VITROS TSH3 LOT 0890 RESULT OF 3.354 UIU/ML (EUTHYROID) SAMPLE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24223876 ↗
• MalfunctionJan 30, 2026Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT DISCORDANT, LOWER THAN EXPECTED TSH RESULTS WERE OBTAINED WHEN MULTIPLE PATIENT SAMPLES WERE TESTED USING VITROS TSH LOT 7450 AND LOT 7470 ON A VITROS XT 7600 INTEGRATED SYSTEM. THE VITROS TSH RESULTS WERE DISCORDANT WHEN COMPARED TO VITROS TSH3 RESULTS FOR THE SAMPLES. SAMPLE P4, VITROS TSH LOT 7450 RESULT OF 0.241 MIU/L (HYPERTHYROID) VERSUS THE VITROS TSH3 LOT 0890 RESULT OF 0.468 UIU/ML (EUTHYROID) SAMPLE P55, VITROS TSH LOT 7450 RESULT OF 0.280 MIU/L (HYPERTHYROID) VERSUS THE VITROS TSH3 LOT 0890 RESULT OF 0.455 UIU/ML (EUTHYROID) SAMPLE P82, VITROS TSH LOT 7450 RESULT OF 0.395 MIU/L (HYPERTHYROID) VERSUS THE VITROS TSH3 LOT 0890 RESULT OF 0.668 UIU/ML (EUTHYROID) SAMPLE P116, VITROS TSH LOT 7450 RESULT OF <0.015 MIU/L (HYPERTHYROID) VERSUS THE VITROS TSH3 LOT 0890 RESULT OF 1.962 UIU/ML (EUTHYROID) SAMPLE P136, VITROS TSH LOT 7450 RESULT OF 0.156 MIU/L (HYPERTHYROID) VERSUS THE VITROS TSH3 LOT 0890 RESULT OF 1.848 UIU/ML (EUTHYROID) SAMPLE P155, VITROS TSH LOT 7450 RESULT OF <0.015 MIU/L (HYPERTHYROID) VERSUS THE VITROS TSH3 LOT 0890 RESULT OF 3.354 UIU/ML (EUTHYROID) SAMPLE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24223872 ↗
• MalfunctionJan 30, 2026Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT DISCORDANT, LOWER THAN EXPECTED TSH RESULTS WERE OBTAINED WHEN MULTIPLE PATIENT SAMPLES WERE TESTED USING VITROS TSH LOT 7450 AND LOT 7470 ON A VITROS XT 7600 INTEGRATED SYSTEM. THE VITROS TSH RESULTS WERE DISCORDANT WHEN COMPARED TO VITROS TSH3 RESULTS FOR THE SAMPLES. SAMPLE P4, VITROS TSH LOT 7450 RESULT OF 0.241 MIU/L (HYPERTHYROID) VERSUS THE VITROS TSH3 LOT 0890 RESULT OF 0.468 UIU/ML (EUTHYROID) SAMPLE P55, VITROS TSH LOT 7450 RESULT OF 0.280 MIU/L (HYPERTHYROID) VERSUS THE VITROS TSH3 LOT 0890 RESULT OF 0.455 UIU/ML (EUTHYROID) SAMPLE P82, VITROS TSH LOT 7450 RESULT OF 0.395 MIU/L (HYPERTHYROID) VERSUS THE VITROS TSH3 LOT 0890 RESULT OF 0.668 UIU/ML (EUTHYROID) SAMPLE P116, VITROS TSH LOT 7450 RESULT OF <0.015 MIU/L (HYPERTHYROID) VERSUS THE VITROS TSH3 LOT 0890 RESULT OF 1.962 UIU/ML (EUTHYROID) SAMPLE P136, VITROS TSH LOT 7450 RESULT OF 0.156 MIU/L (HYPERTHYROID) VERSUS THE VITROS TSH3 LOT 0890 RESULT OF 1.848 UIU/ML (EUTHYROID) SAMPLE P155, VITROS TSH LOT 7450 RESULT OF <0.015 MIU/L (HYPERTHYROID) VERSUS THE VITROS TSH3 LOT 0890 RESULT OF 3.354 UIU/ML (EUTHYROID) SAMPLE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24223837 ↗
• MalfunctionJan 30, 2026Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT DISCORDANT, LOWER THAN EXPECTED TSH RESULTS WERE OBTAINED WHEN MULTIPLE PATIENT SAMPLES WERE TESTED USING VITROS TSH LOT 7450 AND LOT 7470 ON A VITROS XT 7600 INTEGRATED SYSTEM. THE VITROS TSH RESULTS WERE DISCORDANT WHEN COMPARED TO VITROS TSH3 RESULTS FOR THE SAMPLES. SAMPLE P4, VITROS TSH LOT 7450 RESULT OF 0.241 MIU/L (HYPERTHYROID) VERSUS THE VITROS TSH3 LOT 0890 RESULT OF 0.468 UIU/ML (EUTHYROID) SAMPLE P55, VITROS TSH LOT 7450 RESULT OF 0.280 MIU/L (HYPERTHYROID) VERSUS THE VITROS TSH3 LOT 0890 RESULT OF 0.455 UIU/ML (EUTHYROID) SAMPLE P82, VITROS TSH LOT 7450 RESULT OF 0.395 MIU/L (HYPERTHYROID) VERSUS THE VITROS TSH3 LOT 0890 RESULT OF 0.668 UIU/ML (EUTHYROID) SAMPLE P116, VITROS TSH LOT 7450 RESULT OF <0.015 MIU/L (HYPERTHYROID) VERSUS THE VITROS TSH3 LOT 0890 RESULT OF 1.962 UIU/ML (EUTHYROID) SAMPLE P136, VITROS TSH LOT 7450 RESULT OF 0.156 MIU/L (HYPERTHYROID) VERSUS THE VITROS TSH3 LOT 0890 RESULT OF 1.848 UIU/ML (EUTHYROID) SAMPLE P155, VITROS TSH LOT 7450 RESULT OF <0.015 MIU/L (HYPERTHYROID) VERSUS THE VITROS TSH3 LOT 0890 RESULT OF 3.354 UIU/ML (EUTHYROID) SAMPLE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24223823 ↗
• MalfunctionJan 20, 2026High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED TSH RESULTS WERE OBTAINED FROM A SINGLE PATIENT SAMPLE TESTED USING VITROS IMMUNODIAGNOSTICS PRODUCTS TSH REAGENT, LOTS 7530 AND 7560, ON TWO DIFFERENT VITROS XT 7600 INTEGRATED SYSTEMS. THE RESULTS WERE CONSIDERED DISCORDANT WHEN COMPARED TO ANOTHER RESULT OBTAINED FROM A SECOND SAMPLE FROM THE SAME PATIENT, TESTED ON A DIFFERENT VITROS XT 7600 INTEGRATED SYSTEM AT AN ALTERNATE CUSTOMER SITE. VITROS XT 7600 INTEGRATED SYSTEM: S/N (B)(6) (J1): SAMPLE 2, VITROS TSH LOT 7530 RESULTS OF 5.64 UIU/ML (HYPOTHYROID) VS. THE EXPECTED RESULT OF 2.66 UIU/ML (EUTHYROID). VITROS XT 7600 INTEGRATED SYSTEM: S/N (B)(6) (J2): SAMPLE 2, VITROS TSH LOT 7530 RESULT OF 5.58 UIU/ML (HYPOTHYROID) VS. THE EXPECTED RESULT OF 2.66 UIU/ML (EUTHYROID). VITROS XT 7600 INTEGRATED SYSTEM: S/N (B)(6) (J2): SAMPLE 2, VITROS TSH LOT 7560 RESULT OF 5.63 UIU/ML (HYPOTHYROID) VS. THE EXPECTED RESULT OF 2.66 UIU/ML (EUTHYROID). 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 TSH RESU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24123263 ↗