VITROS 1632660Recalls & reported problems
Ortho-Clinical Diagnostics, Inc. · VITROS Chemistry Products Li Slides · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10758750009466), received between Aug 7, 2025 and Aug 7, 2026 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Low 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.
Reports received per month
Most reported problems
Device problems
- Low Test Results4
- High Test Results3
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 7, 2026Low Test Results
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50176219 ↗MalfunctionAug 7, 2025High Test Results; Low Test Results; High Test Results; Low Test Results
A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED LITHIUM (LI) RESULTS AND HIGHER THAN EXPECTED AMMONIA (AMON) RESULTS WERE OBTAINED FROM COLLEGE OF AMERICAN PATHOLOGISTS (CAP) PROFICIENCY SAMPLE FLUIDS USING VITROS CHEMISTRY PRODUCTS LI REAGENT LOTS 3129-0124-0247 AND 3130-0125-4996 AND VITROS CHEMISTRY PRODUCTS AMON REAGENT LOTS 1020-0267-1157 AND 1020- 0267-3613 ON TWO VITROS XT 7600 INTEGRATED SYSTEMS. RESULTS FROM VITROS XT7600 SYSTEM, S/N (B)(6) (J1) VITROS LI SLIDE LOT 3129-0124-0247 CAP SAMPLE CHM-10 VITROS LI RESULT OF 0.9 MMOL/L VS AN EXPECTED RESULT OF 1.7 MMOL/L RESULTS FROM VITROS XT7600 SYSTEM, S/N (B)(6) (J2) VITROS LI SLIDE LOT 3129-0124-0247 CAP SAMPLE CHM-10 VITROS LI RESULT OF 1.0 MMOL/L VS AN EXPECTED RESULT OF 1.7 MMOL/L VITROS LI SLIDE LOT 3130-0125-4996 CAP SAMPLE CHM-10 VITROS LI RESULT OF 0.9 MMOL/L VS AN EXPECTED RESULT OF 1.7 MMOL/L RESULTS FROM VITROS XT7600 INTEGRATED SYSTEM, S/N (B)(6) (J2) VITROS AMON SLIDE LOT 1020-0267-1157 CAP SAMPLE CHM-10 VITROS AMON RESULT OF 459.0 UMOL/L VS AN EXPECTED RESULT OF 366.2 UMOL/L VITROS AMON SLIDE LOT 1020-0267-3613 CAP SAMPLE CHM-10 VITROS AMON
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22741951 ↗MalfunctionAug 7, 2025High Test Results; Low Test Results; High Test Results; Low Test Results
A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED LITHIUM (LI) RESULTS AND HIGHER THAN EXPECTED AMMONIA (AMON) RESULTS WERE OBTAINED FROM COLLEGE OF AMERICAN PATHOLOGISTS (CAP) PROFICIENCY SAMPLE FLUIDS USING VITROS CHEMISTRY PRODUCTS LI REAGENT LOTS 3129-0124-0247 AND 3130-0125-4996 AND VITROS CHEMISTRY PRODUCTS AMON REAGENT LOTS 1020-0267-1157 AND 1020- 0267-3613 ON TWO VITROS XT 7600 INTEGRATED SYSTEMS. RESULTS FROM VITROS XT7600 SYSTEM, S/N (B)(6) (J1) VITROS LI SLIDE LOT 3129-0124-0247 CAP SAMPLE CHM-10 VITROS LI RESULT OF 0.9 MMOL/L VS AN EXPECTED RESULT OF 1.7 MMOL/L RESULTS FROM VITROS XT7600 SYSTEM, S/N (B)(6) (J2) VITROS LI SLIDE LOT 3129-0124-0247 CAP SAMPLE CHM-10 VITROS LI RESULT OF 1.0 MMOL/L VS AN EXPECTED RESULT OF 1.7 MMOL/L VITROS LI SLIDE LOT 3130-0125-4996 CAP SAMPLE CHM-10 VITROS LI RESULT OF 0.9 MMOL/L VS AN EXPECTED RESULT OF 1.7 MMOL/L RESULTS FROM VITROS XT7600 INTEGRATED SYSTEM, S/N (B)(6) (J2) VITROS AMON SLIDE LOT 1020-0267-1157 CAP SAMPLE CHM-10 VITROS AMON RESULT OF 459.0 UMOL/L VS AN EXPECTED RESULT OF 366.2 UMOL/L VITROS AMON SLIDE LOT 1020-0267-3613 CAP SAMPLE CHM-10 VITROS AMON
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22741933 ↗MalfunctionAug 7, 2025High Test Results; Low Test Results; High Test Results; Low Test Results
A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED LITHIUM (LI) RESULTS AND HIGHER THAN EXPECTED AMMONIA (AMON) RESULTS WERE OBTAINED FROM COLLEGE OF AMERICAN PATHOLOGISTS (CAP) PROFICIENCY SAMPLE FLUIDS USING VITROS CHEMISTRY PRODUCTS LI REAGENT LOTS 3129-0124-0247 AND 3130-0125-4996 AND VITROS CHEMISTRY PRODUCTS AMON REAGENT LOTS 1020-0267-1157 AND 1020- 0267-3613 ON TWO VITROS XT 7600 INTEGRATED SYSTEMS. RESULTS FROM VITROS XT7600 SYSTEM, S/N (B)(6) (J1) VITROS LI SLIDE LOT 3129-0124-0247 CAP SAMPLE CHM-10 VITROS LI RESULT OF 0.9 MMOL/L VS AN EXPECTED RESULT OF 1.7 MMOL/L RESULTS FROM VITROS XT7600 SYSTEM, S/N (B)(6) (J2) VITROS LI SLIDE LOT 3129-0124-0247 CAP SAMPLE CHM-10 VITROS LI RESULT OF 1.0 MMOL/L VS AN EXPECTED RESULT OF 1.7 MMOL/L VITROS LI SLIDE LOT 3130-0125-4996 CAP SAMPLE CHM-10 VITROS LI RESULT OF 0.9 MMOL/L VS AN EXPECTED RESULT OF 1.7 MMOL/L RESULTS FROM VITROS XT7600 INTEGRATED SYSTEM, S/N (B)(6) (J2) VITROS AMON SLIDE LOT 1020-0267-1157 CAP SAMPLE CHM-10 VITROS AMON RESULT OF 459.0 UMOL/L VS AN EXPECTED RESULT OF 366.2 UMOL/L VITROS AMON SLIDE LOT 1020-0267-3613 CAP SAMPLE CHM-10 VITROS AMON
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22737553 ↗
Other FLAME PHOTOMETRY, LITHIUM devices
- Roche 9180 Lithium Electrode 3110664180Roche Diagnostics GmbH · FLAME PHOTOMETRY, LITHIUM1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page