VITROS 6801042Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10758750001019), received between Feb 27, 2023 and Mar 12, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (7 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 12, 2026Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT NEGATIVELY BIASED VITROS MYOGLOBIN (MYOG) RESULTS OBTAINED FROM NON-VITROS BIORAD LOT 1003110 LEVEL 1 QUALITY CONTROL FLUID USING VITROS IMMUNODIAGNOSTICS PRODUCTS MYOG REAGENT LOT 2670, ON A VITROS XT7600 INTEGRATED SYSTEM. BIORAD LOT 1003110 L1 VITROS MYOG RESULTS OF 110.9, 110.6 AND 113.0 NG/ML VS. THE EXPECTED VITROS MYOG VALUE OF 130 NG/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 RESULTS WERE OBTAINED FROM NON-PATIENT QUALITY CONTROL FLUIDS. 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 24581750 ↗
• MalfunctionFeb 9, 2026Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED VITROS MYOGLOBIN (MYOG) LOT 2600 RESULTS WERE OBTAINED WHEN THE CUSTOMER WAS PROCESSING A SINGLE LEVEL OF NON-VITROS BIORAD QUALITY CONTROL FLUID ON A VITROS XT 7600 INTEGRATED SYSTEM. BIORAD LEVEL 1 (LOT 1003100) MYOG RESULTS OF 118.6, 116.0, 117.3, 120.6, AND 120.3 NG/ML VERSUS THE EXPECTED RESULT OF 134.8 NG/ML (BIORAD PEER MEAN) 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 MYOG RESULTS WERE OBTAINED WHEN THE CUSTOMER WAS PROCESSING A NON-PATIENT FLUID. 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 REPORTABILITY ASSESSMENT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24298698 ↗
• MalfunctionFeb 9, 2026Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED VITROS MYOGLOBIN (MYOG) LOT 2600 RESULTS WERE OBTAINED WHEN THE CUSTOMER WAS PROCESSING A SINGLE LEVEL OF NON-VITROS BIORAD QUALITY CONTROL FLUID ON A VITROS XT 7600 INTEGRATED SYSTEM. BIORAD LEVEL 1 (LOT 1003100) MYOG RESULTS OF 118.6, 116.0, 117.3, 120.6, AND 120.3 NG/ML VERSUS THE EXPECTED RESULT OF 134.8 NG/ML (BIORAD PEER MEAN) 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 MYOG RESULTS WERE OBTAINED WHEN THE CUSTOMER WAS PROCESSING A NON-PATIENT FLUID. 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 REPORTABILITY ASSESSMENT 613313.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24298689 ↗
• MalfunctionMar 2, 2023Low Test Results; Low Test Results

  THE CUSTOMER CONTACTED ORTHO TO REPORT A LOWER THAN EXPECTED MYOGLOBIN RESULT OBTAINED FROM A PREVIOUSLY REPORTED CAP PROFICIENCY FLUID PROCESSED USING VITROS MYOGLOBIN REAGENT LOT 1600 ON A VITROS 5600 INTEGRATED SYSTEM. CAP PROFICIENCY SAMPLE B = 55 NG/ML VERSUS EXPECTED 65 NG/ML BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED COULD LEAD TO INAPPROPRIATE PHYSICIAN ACTION THEY WERE TO OCCUR UNDETECTED. THE LOWER THAN EXPECTED VITROS MYOGLOBIN RESULT WAS OBTAINED FROM A PREVIOUSLY REPORTED CAP PROFICIENCY SAMPLE AND WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS (ORTHO) COMPLAINT NUMBER (B)(4)/ REPORTABIITY ASSESSMENT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16467016 ↗
• MalfunctionMar 2, 2023Low Test Results; Low Test Results

  THE CUSTOMER REPORTED LOWER THAN EXPECTED MYOGLOBIN RESULTS WERE OBTAINED FROM A NON-VITROS MAS CONTROL LOT CX023630 PROCESSED USING VITROS MYO REAGENT LOT 1940 ON A VITROS XT7600 INTEGRATED SYSTEM. MAS LEVEL 1 = 54.969, 56.991 NG/ML VERSUS PACKAGE INSERT MEAN = 67.0 NG/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 UNEXPECTED VITROS MYOGLOBIN 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 WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THE EVENT. THIS IS DEVICE 2 OF 2. DEVICE 1 WAS FOR MDR 3007111389-2023-00033. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. COMPLAINT NUMBER (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16466407 ↗
• MalfunctionFeb 28, 2023Low Test Results; Low Test Results

  THE CUSTOMER OBTAINED A LOWER THAN EXPECTED MYOGLOBIN (MYO) RESULT FROM A PREVIOUSLY RUN PROFICIENCY FLUID PROCESSED USING VITROS MYO REAGENT LOT 1720 ON A VITROS 5600 INTEGRATED SYSTEM. PROFICIENCY MYO = 61.2 NG/ML VERSUS ORIGINALLY REPORTED MYO = 101 NG/ML BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED COULD LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF UNDETECTED. THE LOW VITROS MYOGLOBIN RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. COMPLAINT NUMBER (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16451960 ↗
• MalfunctionFeb 27, 2023Low Test Results; Low Test Results

  THE CUSTOMER REPORTED LOWER THAN EXPECTED MYOGLOBIN RESULTS WERE OBTAINED FROM A NON-VITROS MAS CONTROL LOT CX023630 PROCESSED USING VITROS MYO REAGENT LOT 1940 ON A VITROS XT7600 INTEGRATED SYSTEM. MAS LEVEL 1 = 54.969, 56.991 NG/ML VERSUS PACKAGE INSERT MEAN = 67.0 NG/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 UNEXPECTED VITROS MYOGLOBIN 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 WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THE EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. COMPLAINT NUMBER (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16449288 ↗