VITROS 8383051Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10758750004829), received between Jan 10, 2025 and Jan 10, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (5 reports).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Jul 13, 2020Terminated

   Etrombopag Interference for VITROS Chemistry Products: TBIL Slides, VITROS BuBc Slides and VITROS XT TBIL-ALKP Slides

   Z-2874-2020 · Root cause: Other · FDA record ↗

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 10, 2025Low Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTIONS CENTER (TSC) TO REPORT THAT VITROS BU QUALITY CONTROL RESULTS OBTAINED FROM A SINGLE VITROS PERFORMANCE VERIFIER (PV) FLUID WERE LOWER THAN EXPECTED FOR WHEN USING TWO DIFFERENT LOTS OF VITROS BUBC MICROSLIDES TESTED ON A VITROS XT 7600 INTEGRATED SYSTEM AND A VITROS XT 3400 CHEMISTRY SYSTEM. J1 (S/N (B)(6) WITH VITROS BUBC LOT 0243-0474-4749 VITROS PV II W1667 BU RESULTS 0.0, 0.0, 0.0, 0.0 MG/DL VERSUS THE RANGE OF MEANS MIDPOINT RESULT OF 8.5 MG/DL. J2 (S/N (B)(6) USING VITROS BUBC LOT 0243-0474-1655 VITROS PV II W1667 BU RESULTS 0.0 MG/DL VERSUS THE RANGE OF MEANS MIDPOINT RESULT OF 8.5 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 LOWER-THAN-EXPECTED VITROS BU RESULTS WERE OBTAINED FROM A NON-PATIENT QUALITY CONTROL FLUID. THERE WERE NO ALLEGATIONS OF PATIENT HARM AS A RESULT OF THE EVENT. THIS REPORT IS NUMBER FIVE OF FIVE MDR'S FOR THIS EVENT. FIVE 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS FIVE DEVICES WERE INVOLVED. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (O

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21125606 ↗
• MalfunctionJan 10, 2025Low Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTIONS CENTER (TSC) TO REPORT THAT VITROS BU QUALITY CONTROL RESULTS OBTAINED FROM A SINGLE VITROS PERFORMANCE VERIFIER (PV) FLUID WERE LOWER THAN EXPECTED FOR WHEN USING TWO DIFFERENT LOTS OF VITROS BUBC MICROSLIDES TESTED ON A VITROS XT 7600 INTEGRATED SYSTEM AND A VITROS XT 3400 CHEMISTRY SYSTEM. J1 (S/N (B)(6)) WITH VITROS BUBC LOT 0243-0474-4749 VITROS PV II W1667 BU RESULTS 0.0, 0.0, 0.0, 0.0 MG/DL VERSUS THE RANGE OF MEANS MIDPOINT RESULT OF 8.5 MG/DL. J2 (S/N (B)(6)) USING VITROS BUBC LOT 0243-0474-1655 VITROS PV II W1667 BU RESULTS 0.0 MG/DL VERSUS THE RANGE OF MEANS MIDPOINT RESULT OF 8.5 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 LOWER-THAN-EXPECTED VITROS BU RESULTS WERE OBTAINED FROM A NON-PATIENT QUALITY CONTROL FLUID. THERE WERE NO ALLEGATIONS OF PATIENT HARM AS A RESULT OF THE EVENT. THIS REPORT IS NUMBER FOUR OF FIVE MDR'S FOR THIS EVENT. FIVE 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS FIVE DEVICES WERE INVOLVED. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21125394 ↗
• MalfunctionJan 10, 2025Low Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTIONS CENTER (TSC) TO REPORT THAT VITROS BU QUALITY CONTROL RESULTS OBTAINED FROM A SINGLE VITROS PERFORMANCE VERIFIER (PV) FLUID WERE LOWER THAN EXPECTED FOR WHEN USING TWO DIFFERENT LOTS OF VITROS BUBC MICROSLIDES TESTED ON A VITROS XT 7600 INTEGRATED SYSTEM AND A VITROS XT 3400 CHEMISTRY SYSTEM. J1 (S/N (B)(6) WITH VITROS BUBC LOT 0243-0474-4749 VITROS PV II W1667 BU RESULTS 0.0, 0.0, 0.0, 0.0 MG/DL VERSUS THE RANGE OF MEANS MIDPOINT RESULT OF 8.5 MG/DL. J2 (S/N (B)(6) USING VITROS BUBC LOT 0243-0474-1655 VITROS PV II W1667 BU RESULTS 0.0 MG/DL VERSUS THE RANGE OF MEANS MIDPOINT RESULT OF 8.5 MG/DL 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 BU RESULTS WERE OBTAINED FROM A NON-PATIENT QUALITY CONTROL FLUID. THERE WERE NO ALLEGATIONS OF PATIENT HARM AS A RESULT OF THE EVENT. THIS REPORT IS NUMBER THREE OF FIVE MDR'S FOR THIS EVENT. FIVE 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS FIVE DEVICES WERE INVOLVED. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (O

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21125335 ↗
• MalfunctionJan 10, 2025Low Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTIONS CENTER (TSC) TO REPORT THAT VITROS BU QUALITY CONTROL RESULTS OBTAINED FROM A SINGLE VITROS PERFORMANCE VERIFIER (PV) FLUID WERE LOWER THAN EXPECTED FOR WHEN USING TWO DIFFERENT LOTS OF VITROS BUBC MICROSLIDES TESTED ON A VITROS XT 7600 INTEGRATED SYSTEM AND A VITROS XT 3400 CHEMISTRY SYSTEM. J1 (S/N (B)(6) WITH VITROS BUBC LOT 0243-0474-4749 VITROS PV II W1667 BU RESULTS 0.0, 0.0, 0.0, 0.0 MG/DL VERSUS THE RANGE OF MEANS MIDPOINT RESULT OF 8.5 MG/DL. J2 (S/N (B)(6) USING VITROS BUBC LOT 0243-0474-1655 VITROS PV II W1667 BU RESULTS 0.0 MG/DL VERSUS THE RANGE OF MEANS MIDPOINT RESULT OF 8.5 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 LOWER-THAN-EXPECTED VITROS BU RESULTS WERE OBTAINED FROM A NON-PATIENT QUALITY CONTROL FLUID. THERE WERE NO ALLEGATIONS OF PATIENT HARM AS A RESULT OF THE EVENT. THIS REPORT IS NUMBER TWO OF FIVE MDR'S FOR THIS EVENT. FIVE 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS FIVE DEVICES WERE INVOLVED. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (OR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21125070 ↗
• MalfunctionJan 10, 2025Low Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTIONS CENTER (TSC) TO REPORT THAT VITROS BU QUALITY CONTROL RESULTS OBTAINED FROM A SINGLE VITROS PERFORMANCE VERIFIER (PV) FLUID WERE LOWER THAN EXPECTED FOR WHEN USING TWO DIFFERENT LOTS OF VITROS BUBC MICROSLIDES TESTED ON A VITROS XT 7600 INTEGRATED SYSTEM AND A VITROS XT 3400 CHEMISTRY SYSTEM. J1 (S/N (B)(6)) WITH VITROS BUBC LOT 0243-0474-4749 VITROS PV II W1667 BU RESULTS 0.0, 0.0, 0.0, 0.0 MG/DL VERSUS THE RANGE OF MEANS MIDPOINT RESULT OF 8.5 MG/DL. J2 (S/N (B)(6) USING VITROS BUBC LOT 0243-0474-1655 VITROS PV II W1667 BU RESULTS 0.0 MG/DL VERSUS THE RANGE OF MEANS MIDPOINT RESULT OF 8.5 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 LOWER-THAN-EXPECTED VITROS BU RESULTS WERE OBTAINED FROM A NON-PATIENT QUALITY CONTROL FLUID. THERE WERE NO ALLEGATIONS OF PATIENT HARM AS A RESULT OF THE EVENT. THIS REPORT IS NUMBER ONE OF FIVE MDR'S FOR THIS EVENT. FIVE 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS FIVE DEVICES WERE INVOLVED. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (O

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21124934 ↗