VITROS 8150112Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10758750004454), received between Sep 3, 2024 and Sep 23, 2026 — classified as 8 malfunctions.

The most frequently reported specific device problem is “High Test Results” (8 reports).

1 FDA recall record name this device's identifier, 1 still open.

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 29, 2025Open, Classified

   VITROS Chemistry Products LAC Slides on VITROS XT 3400 and VITROS XT 7600 Systems are experiencing an increased occurrence of calibration failure related to lots from coating 0130 and above with Condition Code TH4-63J during calibration, causing the delay of lac test results and potentially impact patient management. The issue was identified by QuidelOrtho through an increase in customer complaints compared to the historical baseline with average failure rate of 1% for coating 0130 in 2025 while average of failure rate for other coating was 0.06% in 2025 and average of failure rate for all coatings is 0.03% for 2024.

   Z-2560-2025 · Root cause: Device Design · FDA record ↗

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.

• MalfunctionSep 23, 2026High Test Results; Low Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50872030 ↗
• MalfunctionFeb 26, 2025High Test Results; High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED LACTATE RESULTS WERE OBTAINED FROM COLLEGE OF AMERICAN PATHOLOGISTS (CAP) PROFICIENCY SAMPLES USING VITROS CHEMISTRY PRODUCTS LACTATE (LAC) SLIDES LOT 3533-0125-2686 ON A VITROS 5600 INTEGRATED SYSTEM. CAP SAMPLE CHM-12 RESULTS OF 5.37 AND 5.25 MMOL/L VS AN EXPECTED RESULT OF 4.52 MMOL/L CAP SAMPLE CHM-14 RESULT OF 4.5 MMOL/L VS AN EXPECTED RESULT OF 3.87 MMOL/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 LAC RESULTS WERE OBTAINED FROM PROFICIENCY SAMPLES AND NO RESULTS WERE REPORTED FROM THE LABORATORY. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER THREE OF THREE MDRS FOR THIS EVENT. THREE 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS THREE 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 21473135 ↗
• MalfunctionFeb 26, 2025High Test Results; High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED LACTATE RESULTS WERE OBTAINED FROM COLLEGE OF AMERICAN PATHOLOGISTS (CAP) PROFICIENCY SAMPLES USING VITROS CHEMISTRY PRODUCTS LACTATE (LAC) SLIDES LOT 3533-0125-2686 ON A VITROS 5600 INTEGRATED SYSTEM. CAP SAMPLE CHM-12 RESULTS OF 5.37 AND 5.25 MMOL/L VS AN EXPECTED RESULT OF 4.52 MMOL/L CAP SAMPLE CHM-14 RESULT OF 4.5 MMOL/L VS AN EXPECTED RESULT OF 3.87 MMOL/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 LAC RESULTS WERE OBTAINED FROM PROFICIENCY SAMPLES AND NO RESULTS WERE REPORTED FROM THE LABORATORY. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER TWO OF THREE MDRS FOR THIS EVENT. THREE 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS THREE 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 21473132 ↗
• MalfunctionFeb 26, 2025High Test Results; High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED LACTATE RESULTS WERE OBTAINED FROM COLLEGE OF AMERICAN PATHOLOGISTS (CAP) PROFICIENCY SAMPLES USING VITROS CHEMISTRY PRODUCTS LACTATE (LAC) SLIDES LOT 3533-0125-2686 ON A VITROS 5600 INTEGRATED SYSTEM. CAP SAMPLE CHM-12 RESULTS OF 5.37 AND 5.25 MMOL/L VS AN EXPECTED RESULT OF 4.52 MMOL/L CAP SAMPLE CHM-14 RESULT OF 4.5 MMOL/L VS AN EXPECTED RESULT OF 3.87 MMOL/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 LAC RESULTS WERE OBTAINED FROM PROFICIENCY SAMPLES AND NO RESULTS WERE REPORTED FROM THE LABORATORY. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER ONE OF THREE MDRS FOR THIS EVENT. THREE 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS THREE 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 21473112 ↗
• MalfunctionSep 3, 2024High Test Results; High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED VITROS LACTATE (LAC) RESULTS WERE OBTAINED FROM FOUR DIFFERENT PATIENT SAMPLES WHEN TESTED ON A VITROS XT 7600 INTEGRATED SYSTEM. THE AFFECTED RESULTS WERE PROCESSED USING A NEW COLLECTION DEVICE (PLASMA SEPARATOR TUBE (PST)) AND WERE HIGHER THAN EXPECTED WHEN COMPARED TO THE RESULTS FROM THE SAME PATIENT SAMPLES PROCESSED USING THE CUSTOMER'S IN-USE COLLECTION DEVICE, THE FLUORIDE OXALATE TUBE. PATIENT SAMPLE 4 LAC RESULT OF 4.1 MMOL/L VS. THE EXPECTED RESULT OF 3.5 MMOL/L PATIENT SAMPLE 11 LAC RESULT OF 2.2 MMOL/L VS. THE EXPECTED RESULT OF 0.9 MMOL/L PATIENT SAMPLE 12 LAC RESULT OF 2.5 MMOL/L VS. THE EXPECTED RESULT OF 1.5 MMOL/L PATIENT SAMPLE 19 LAC RESULT OF 2.4 MMOL/L VS. THE EXPECTED RESULT OF 1.9 MMOL/L 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 LAC RESULTS WERE OBSERVED ON PATIENT SAMPLES, HOWEVER THESE RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THERE WERE NO REPORTED ALLEGATIONS OF PATIENT HARM AS A RESULT OF THE EVENT. T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20128457 ↗
• MalfunctionSep 3, 2024High Test Results; High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED VITROS LACTATE (LAC) RESULTS WERE OBTAINED FROM FOUR DIFFERENT PATIENT SAMPLES WHEN TESTED ON A VITROS XT 7600 INTEGRATED SYSTEM. THE AFFECTED RESULTS WERE PROCESSED USING A NEW COLLECTION DEVICE (PLASMA SEPARATOR TUBE (PST)) AND WERE HIGHER THAN EXPECTED WHEN COMPARED TO THE RESULTS FROM THE SAME PATIENT SAMPLES PROCESSED USING THE CUSTOMER'S IN-USE COLLECTION DEVICE, THE FLUORIDE OXALATE TUBE. PATIENT SAMPLE 4 LAC RESULT OF 4.1 MMOL/L VS. THE EXPECTED RESULT OF 3.5 MMOL/L PATIENT SAMPLE 11 LAC RESULT OF 2.2 MMOL/L VS. THE EXPECTED RESULT OF 0.9 MMOL/L PATIENT SAMPLE 12 LAC RESULT OF 2.5 MMOL/L VS. THE EXPECTED RESULT OF 1.5 MMOL/L PATIENT SAMPLE 19 LAC RESULT OF 2.4 MMOL/L VS. THE EXPECTED RESULT OF 1.9 MMOL/L 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 LAC RESULTS WERE OBSERVED ON PATIENT SAMPLES, HOWEVER THESE RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THERE WERE NO REPORTED ALLEGATIONS OF PATIENT HARM AS A RESULT OF THE EVENT. T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20128399 ↗
• MalfunctionSep 3, 2024High Test Results; High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED VITROS LACTATE (LAC) RESULTS WERE OBTAINED FROM FOUR DIFFERENT PATIENT SAMPLES WHEN TESTED ON A VITROS XT 7600 INTEGRATED SYSTEM. THE AFFECTED RESULTS WERE PROCESSED USING A NEW COLLECTION DEVICE (PLASMA SEPARATOR TUBE (PST)) AND WERE HIGHER THAN EXPECTED WHEN COMPARED TO THE RESULTS FROM THE SAME PATIENT SAMPLES PROCESSED USING THE CUSTOMER'S IN-USE COLLECTION DEVICE, THE FLUORIDE OXALATE TUBE. PATIENT SAMPLE 4 LAC RESULT OF 4.1 MMOL/L VS. THE EXPECTED RESULT OF 3.5 MMOL/L PATIENT SAMPLE 11 LAC RESULT OF 2.2 MMOL/L VS. THE EXPECTED RESULT OF 0.9 MMOL/L PATIENT SAMPLE 12 LAC RESULT OF 2.5 MMOL/L VS. THE EXPECTED RESULT OF 1.5 MMOL/L PATIENT SAMPLE 19 LAC RESULT OF 2.4 MMOL/L VS. THE EXPECTED RESULT OF 1.9 MMOL/L 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 LAC RESULTS WERE OBSERVED ON PATIENT SAMPLES, HOWEVER THESE RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THERE WERE NO REPORTED ALLEGATIONS OF PATIENT HARM AS A RESULT OF THE EVENT. T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20128395 ↗
• MalfunctionSep 3, 2024High Test Results; High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED VITROS LACTATE (LAC) RESULTS WERE OBTAINED FROM FOUR DIFFERENT PATIENT SAMPLES WHEN TESTED ON A VITROS XT 7600 INTEGRATED SYSTEM. THE AFFECTED RESULTS WERE PROCESSED USING A NEW COLLECTION DEVICE (PLASMA SEPARATOR TUBE (PST)) AND WERE HIGHER THAN EXPECTED WHEN COMPARED TO THE RESULTS FROM THE SAME PATIENT SAMPLES PROCESSED USING THE CUSTOMER'S IN-USE COLLECTION DEVICE, THE FLUORIDE OXALATE TUBE. PATIENT SAMPLE 4 LAC RESULT OF 4.1 MMOL/L VS. THE EXPECTED RESULT OF 3.5 MMOL/L PATIENT SAMPLE 11 LAC RESULT OF 2.2 MMOL/L VS. THE EXPECTED RESULT OF 0.9 MMOL/L PATIENT SAMPLE 12 LAC RESULT OF 2.5 MMOL/L VS. THE EXPECTED RESULT OF 1.5 MMOL/L PATIENT SAMPLE 19 LAC RESULT OF 2.4 MMOL/L VS. THE EXPECTED RESULT OF 1.9 MMOL/L 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 LAC RESULTS WERE OBSERVED ON PATIENT SAMPLES, HOWEVER THESE RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THERE WERE NO REPORTED ALLEGATIONS OF PATIENT HARM AS A RESULT OF THE EVENT. T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20128213 ↗