VITROS 1387000Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10758750008971), received between Apr 10, 2023 and Oct 8, 2024 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (8 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 8, 2024High Test Results; High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT REPRODUCIBLE HIGHER THAN EXPECTED VITROS FT4 RESULTS AND REPRODUCIBLE LOWER THAN EXPECTED VITROS TSH RESULTS WERE OBTAINED FROM A SINGLE PATIENT SAMPLE TESTED ON A VITROS 5600 INTEGRATED SYSTEM WHEN COMPARED TO FT4 AND TSH RESULTS OBTAINED FROM THE SAME SAMPLE TESTED WITH A NON-VITROS ROCHE COBAS METHOD. PATIENT SAMPLE 2 VITROS FT4 RESULTS OF 3.73 AND 3.85 NG/DL VS. THE ROCHE COBAS FT4 RESULT OF 0.77 NG/DL. PATIENT SAMPLE 2 VITROS TSH RESULTS OF 1.73 AND 1.72 NG/DL VS. THE ROCHE COBAS TSH RESULT OF 17.3 NG/DL. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE VITROS FT4 AND TSH RESULTS OBTAINED FROM THE PATIENT SAMPLE WERE REPORTED OUTSIDE OF THE LABORATORY. THE CUSTOMER STATED THAT NO CORRECTED REPORTS WERE ISSUED, HOWEVER, NO TREATMENT WAS STOPPED, STARTED OR ALTERED BASED ON THE VITROS FT4 AND TSH RESULTS REPORTED. 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 DEV

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20399423 ↗
• MalfunctionSep 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 FREE T4 (FT4) RESULTS WERE OBTAINED FROM NON-VITROS MAS LIQUIMMUNE LOT LIA2802A QUALITY CONTROL (QC) FLUID WHEN USING VITROS IMMUNODIAGNOSTIC PRODUCTS FT4 REAGENT ON A VITROS 5600 INTEGRATED SYSTEM. LEVEL 1 VITROS FT4 RESULT OF 0.070 AND 1.80 NG/DL VERSUS THE EXPECTED RESULT OF 2.87 NG/DL 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 FT4 RESULTS WERE OBTAINED FROM NON-PATIENT FLUID AND 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 20279911 ↗
• MalfunctionApr 10, 2024Low Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT REPRODUCIBLE, LOWER THAN EXPECTED FT4 RESULTS WERE OBTAINED WHEN A NON-VITROS AUDIT MICROCONTROL LINEARITY FLUID WAS PROCESSED USING VITROS FT4 LOT 5430 ON A VITROS XT 7600 INTEGRATED SYSTEM. AUDIT MICROCONTROL (LOT 06997) LB FLUID RESULTS OF 2.00, 2.02 AND 2.11 NG/DL VERUS THE PEER MEAN RESULT OF 2.75 NG/DL 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 FT4 RESULTS WERE OBTAINED WHEN THE CUSTOMER WAS PROCESSING A NON-PATIENT FLUID AND WERE NOT REPORTED FROM THE LABORATORY. 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 19080115 ↗
• MalfunctionSep 20, 2023Low Test Results; Low Test Results

  THE CUSTOMER REPORTED THAT A LOWER THAN EXPECTED VITROS FT4 RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE USING VITROS IMMUNODIAGNOSTIC PRODUCTS FT4 REAGENT ON A VITROS 5600 INTEGRATED SYSTEM. PATIENT SAMPLE 4 RESULT OF 1.72 NG/DL VS. THE EXPECTED RESULT OF 2.24 NG/DL BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THE RESULTS WERE TO RECUR UNDETECTED. THE LOWER THAN EXPECTED VITROS FT4 RESULT WAS NOT REPORTED FROM THE LABORATORY AS IT WAS OBTAINED AS PART OF A PATIENT SAMPLE CORRELATION. THERE WAS NO REPORTED ALLEGATION OF PATIENT HARM AS A RESULT OF THIS 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 17780452 ↗
• MalfunctionSep 19, 2023High Test Results; High Test Results

  THE CUSTOMER REPORTED THAT HIGHER THAN EXPECTED FT4 RESULTS WERE OBTAINED WHEN A LEVEL 1 CONTROL FROM VITROS FREE THYROID CONTROL (FTC) LOT 0761 WAS PROCESSED USING VITROS FT4 REAGENT LOT 5300 ON A VITROS 5600 INTEGRATED SYSTEM. VITROS FTC LEVEL 1 = 1.07, 1.19, 1.13, 1.10, 1.11, 1.08 NG/DL VERSUS THE PI MEAN 0.75 NG/DL 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 FT4 RESULTS WERE GENERATED FROM NON-PATIENT FLUIDS, HOWEVER THE INVESTIGATION CANNOT CONCLUDE THAT PATIENT SAMPLE RESULTS WOULD NOT BE AFFECTED IF THE EVENT WERE TO RECUR UNDETECTED. THERE WERE NO ALLEGATIONS OF PATIENT HARM AS A RESULT OF THE EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. COMPLAINT NUMBER (B)(4)/REPORTABILITY ASSESSMENT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17772483 ↗
• MalfunctionAug 15, 2023Low Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A LOWER THAN EXPECTED VITROS FT4 RESULT WAS OBTAINED FROM AN INSTITUTE FOR QUALITY MANAGEMENT IN HEALTHCARE (IQMH) PROFICIENCY SAMPLE USING A VITROS IMMUNODIAGNOSTIC PRODUCTS FT4 REAGENT ON A VITROS XT 7600 INTEGRATED SYSTEM. IQMH SAMPLE 4 RESULT OF 28 PMOL/L VS. THE IQMH EXPECTED RESULT OF 38 PMOL/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 LOWER THAN EXPECTED VITROS FT4 RESULT WAS FROM NON-PATIENT FLUID AND WAS REPORTED TO THE PROFICIENCY PROVIDER. HOWEVER, THE INVESTIGATION CANNOT RULE OUT THAT PATIENT SAMPLES RESULTS WOULD NOT BE AFFECTED IF THE EVENT WERE TO RECUR UNDETECTED. 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 602820.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17552191 ↗
• MalfunctionJul 24, 2023Low Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED FREE T4 (FT4) RESULTS WERE OBTAINED FROM VITROS FREE THYROID CONTROL (FTC) FLUID WHEN USING VITROS IMMUNODIAGNOSTIC PRODUCTS FT4 REAGENT ON A VITROS 5600 INTEGRATED SYSTEM. FTC LEVEL 2 VITROS FT4 RESULT OF 1.86 NG/DL ON INST J1 VERSUS THE EXPECTED RESULT OF 2.46 NG/DL FTC LEVEL 2 VITROS FT4 RESULTS OF 1.79 NG/DL ON INST J2 VERSUS THE EXPECTED RESULT OF 2.46 NG/DL 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 RESULTS WERE OBTAINED FROM NON-PATIENT SAMPLE QC FLUIDS. 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 NUMBERS (B)(4), (B)(4) AND REPORTABILITY ASSESSMENT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17377814 ↗
• MalfunctionJul 19, 2023Low Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A LOWER THAN EXPECTED FREE T4 (FT4) RESULT WAS OBTAINED FROM A COLLEGE OF AMERICAN PATHOLOGISTS PROFICIENCY SAMPLE PROCESSED USING VITROS IMMUNODIAGNOSTIC PRODUCTS FREE T4 REAGENT LOT 5150 ON A VITROS XT 7600 INTEGRATED SYSTEM. CAP K-01 RESULT OF 1.7 NG/DL VS THE EXPECTED RESULT OF 2.25 NG/DL 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 RESULT WAS FROM A PROFICIENCY SAMPLE AND THE CUSTOMER CONFIRMED THAT NO PATIENT SAMPLE RESULTS HAVE 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 602664.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17348344 ↗
• MalfunctionJun 27, 2023Low Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A LOWER THAN EXPECTED FT4 RESULT FROM A SINGLE PATIENT SAMPLE USING A VITROS IMMUNODIAGNOSTIC PRODUCTS FT4 REAGENT ON A VITROS 5600 INTEGRATED SYSTEM. THE RESULT WAS CONSIDERED LOWER THAN EXPECTED WHEN COMPARED TO A VITROS FT4 RESULT FROM THE SAME SAMPLE OBTAINED FROM A DIFFERENT LOT OF VITROS FT4 REAGENT. PATIENT SAMPLE 1 RESULT OF 1.34 NG/DL VERSUS THE EXPECTED RESULT OF 2.72 NG/DL 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 FT4 RESULT WAS NOT REPORTED FROM THE LABORATORY AND 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 17208283 ↗
• MalfunctionApr 10, 2023High Test Results; Low Test Results; Non Reproducible Results; High Test Results; Low Test Results; Non Reproducible Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A NON-REPRODUCIBLE, LOWER THAN EXPECTED VITROS TSH RESULT AND A NON-REPRODUCIBLE, HIGHER THAN EXPECTED VITROS FT4 RESULT WAS OBTAINED FROM A SAMPLE FROM A SINGLE PATIENT WHEN TESTED ON A VITROS 5600 INTEGRATED SYSTEM. PATIENT A TSH RESULT OF 0.259 MIU/L VERSUS THE EXPECTED RESULT OF 2.21 MIU/L PATIENT A FT4 RESULT OF 2.52 NG/DL VERSUS THE EXPECTED RESULT OF 0.7 NG/DL BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. PATIENT SAMPLE RESULTS WERE REPORTED FROM THE LABORATORY AND TREATMENT WAS BOTH ADMINISTERED AND DELAYED BASED ON THE REPORTED RESULTS. HOWEVER, 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 MDR¿S 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 NUMBERS 2510230, 2513241, 2513241, 2513243, 2513245 AND REPORTABILITY ASSESSMENT 601512.`1

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16709454 ↗