VITROS 6844295Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10758750031795), received between Jun 13, 2023 and Mar 24, 2026 — classified as 8 malfunctions.

The most frequently reported specific device problem is “High Test Results” (4 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 24, 2026High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A HIGHER-THAN-EXPECTED GLUCOSE (GLU) RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE USING VITROS CHEMISTRY PRODUCTS GLU SLIDES LOT 7426-0023-0184 ON A VITROS XT 7600 INTEGRATED SYSTEM. PATIENT SAMPLE RESULT OF 528.0 MG/DL VS THE EXPECTED RESULT OF 78.0 MG/DL 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 GLU RESULT WAS NOT REPORTED FROM THE LABORATORY. THE CUSTOMER HAS CONFIRMED THAT 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 24682583 ↗
• MalfunctionJan 12, 2026Low 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 GLUCOSE (GLU) RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE PROCESSED USING VITROS CHEMISTRY PRODUCTS GLU-CA XT SLIDE LOT: 7426-0023-8065 ON A VITROS XT7600 INTEGRATED SYSTEM (S/N: (B)(6). THE RESULT WAS LOWER THAN EXPECTED COMPARED TO THE RESULTS OBTAINED FOR THE SAME PATIENT SAMPLE ON TWO ALTERNATE VITROS XT7600 SYSTEMS AT THE CUSTOMER SITE. PATIENT SAMPLE RESULT OF <20.0 MG/DL VS THE EXPECTED RESULT OF 254.0 MG/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 GLU RESULT WAS REPORTED FROM THE LABORATORY, AND A CORRECTED REPORT WAS LATER ISSUED FOR THE RESULT OF 254.0 MG/DL. NO TREATMENT WAS ALTERED, INITIATED OR STOPPED BASED UPON THE INITIAL REPORTED RESULT. THERE HAVE BEEN NO REPORTED ALLEGATIONS 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 24046734 ↗
• MalfunctionApr 3, 2025Low Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED GLUCOSE (GLU) RESULTS WERE OBTAINED FROM A SINGLE PATIENT SAMPLE PROCESSED USING VITROS CHEMISTRY PRODUCTS GLU SLIDES LOT 7423-0020-7607 ON A VITROS XT 7600 INTEGRATED SYSTEM. PATIENT SAMPLE RESULTS OF 74.0, 22.0, 25.0, 30.0, AND 64.0 MG/DL VS THE EXPECTED RESULT OF 400.0 MG/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 GLU RESULTS WERE REPORTED FROM THE LABORATORY, HOWEVER THE ORTHO TSC CONFIRMED THAT NO TREATMENT WAS ADMINISTERED BASED ON ANY LOWER-THAN-EXPECTED RESULTS OBTAINED. NO CORRECTED REPORT WAS ISSUED. 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 21761230 ↗
• MalfunctionSep 12, 2024Low Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A NON-REPRODUCIBLE, LOWER THAN EXPECTED RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE USING VITROS GLUCOSE (GLUXT) SLIDE LOT 7419-0016-8376 TESTED ON A VITROS XT 7600 INTEGRATED SYSTEM. VITROS GLUXT PATIENT SAMPLE RESULT OF <20 MG/DL VS. THE REPEAT RESULT OF 198 MG/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 GLUXT RESULT PREDICTED FROM THE PATIENT SAMPLE WAS NOT REPORTED OUTSIDE THE LABORATORY, 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 20201668 ↗
• MalfunctionSep 10, 2024High Test Results; High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED VITROS INTACT PTH (IPTH) RESULTS HAVE OCCURRED WITH MULTIPLE PATIENT SAMPLES WHEN COMPARING DATA FROM A METHOD COMPARISON STUDY BETWEEN THE VITROS IPTH ASSAY AND THE VITROS IPTH2 ASSAY TESTED ON A VITROS XT 7600 INTEGRATED SYSTEM. THE VITROS IPTH REFERENCE INTERVAL: 7.5 - 53.5 PG/ML. THE VITROS IPTH2 REFERENCE INTERVAL: 14.2 - 75.2 PG/ML. CORRELATION SAMPLE 5 VITROS IPTH RESULT OF 77.38 PG/ML (ABOVE THE REFERENCE INTERVAL) VS. THE VITROS IPTH2 RESULT OF 57.98 PG/ML (WITHIN THE REFERENCE INTERVAL). CORRELATION SAMPLE 6 VITROS IPTH RESULT OF 121.08 PG/ML (ABOVE THE REFERENCE INTERVAL) VS. THE VITROS IPTH2 RESULT OF 67.43 PG/ML (WITHIN THE REFERENCE INTERVAL). CORRELATION SAMPLE 21 VITROS IPTH RESULT OF 88.28 PG/ML (ABOVE THE REFERENCE INTERVAL) VS. THE VITROS IPTH2 RESULT OF 62.54 PG/ML (WITHIN THE REFERENCE INTERVAL). CORRELATION SAMPLE 22 VITROS IPTH RESULT OF 78.44 PG/ML (ABOVE THE REFERENCE INTERVAL) VS. THE VITROS IPTH2 RESULT OF 59.59 PG/ML (WITHIN THE REFERENCE INTERVAL). CORRELATION SAMPLE 23 VITROS IPTH RESULT OF 87.25 PG/ML (ABOVE THE REFERENCE INTERVAL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20179571 ↗
• MalfunctionAug 27, 2024Low Test Results; Non Reproducible 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 RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE USING VITROS GLUCOSE (GLUXT) SLIDE LOT 7419-0016-8376 TESTED ON A VITROS XT 7600 INTEGRATED SYSTEM. PATIENT SAMPLE: VITROS GLUXT RESULT OF <20 MG/DL VS. THE REPEAT RESULT OF 151 MG/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 GLUXT RESULT PREDICTED FROM THE PATIENT SAMPLE WAS NOT REPORTED OUTSIDE THE LABORATORY, 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 20075250 ↗
• MalfunctionOct 17, 2023High Test Results; High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A HIGHER THAN EXPECTED GLUCOSE CSF RESULT WAS OBTAINED FROM A VITROS LIQUID PERFORMANCE VERIFIER (LPV) USING VITROS XT CHEMISTRY PRODUCTS GLU-CA SLIDES LOT 7418-0015-1820 ON A VITROS XT 7600 INTEGRATED SYSTEM. VITROS LPV I LOT W9322 VITROS GLUCSF RESULT OF 45.7 MG/DL VS AN EXPECTED RESULT OF 39.4 MG/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 HIGHER THAN EXPECTED VITROS GLUCSF RESULT WAS FROM A NON-PATIENT FLUID AND WAS NOT REPORTED FROM THE LABORATORY. THERE HAS BEEN NO REPORTED ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER (B)(4) AND REPORTABILITY ASSESSMENT 603545.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17948493 ↗
• MalfunctionJun 13, 2023High Test Results; High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A HIGHER THAN EXPECTED VITROS CEREBRAL SPINAL FLUID (CSF) GLUCOSE (GLU) RESULT WAS OBTAINED FROM A SINGLE COLLEGE OF AMERICAN PROFICIENCY (CAP) SURVEY SAMPLE USING VITROS GLU XT REAGENT LOT 7417-0014-4811 PROCESSED ON A VITROS XT7600 INTEGRATED SYSTEM. GLU CSF CAP SAMPLE M-03 RESULT OF 283.0 MG/DL VS. THE EXPECTED RESULT OF 36.6 MG/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 CUSTOMER MADE NO INDICATION THAT VITROS CSF GLU PATIENT RESULTS HAVE BEEN QUESTIONED BY CLINICIANS. THERE WERE NO REPORTED 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 602240.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17118720 ↗