VITROS 8157596Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 10758750010233), received between Mar 13, 2023 and Feb 3, 2026 — classified as 26 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (21 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 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 3, 2026High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED VITROS POTASSIUM (K+) RESULTS WERE OBTAINED FROM A SINGLE PATIENT SAMPLE USING VITROS K+ LOT 4102-1194-8274 TESTED ON A VITROS XT 7600 INTEGRATED SYSTEM. VITROS K+ PATIENT SAMPLE RESULTS OF 3.5, 4.8, 3.6, 5.0, 3.7 MMOL/L VS. THE EXPECTED RESULT OF 2.9 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 PATIENT SAMPLE RESULTS WERE OBTAINED FROM A SINGLE PATIENT SAMPLE AND WERE 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 (ORTHO) COMPLAINT NUMBER (B)(4) AND REPORTABILITY ASSESSMENT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24251687 ↗
• MalfunctionSep 18, 2025Low Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A LOWER THAN EXPECTED POTASSIUM (K+) RESULT WAS OBTAINED FROM A PATIENT SAMPLE PROCESSED DURING CORRELATION TESTING USING VITROS CHEMISTRY PRODUCTS K+ SLIDES LOT 4102-1162-9602 ON A VITROS 350 CHEMISTRY SYSTEM. THE VITROS RESULT FOR THE SAMPLE WAS DISCORDANT WHEN COMPARED TO THE RESULT OBTAINED FROM THE SAME SAMPLE USING A NON-VITROS EXIAS METHOD. PATIENT SAMPLE VITROS K+ RESULT OF 3.8 MMOL/L VS THE EXPECTED RESULT OF 6.69 MMOL/L 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 K+ RESULT WAS OBTAINED DURING A METHOD TO METHOD CORRELATION TEST AND WAS NOT REPORTED FROM THE LABORATORY. 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 612044.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23089659 ↗
• MalfunctionJul 8, 2024Low Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A LOWER THAN EXPECTED VITROS POTASSIUM (K+) RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE USING VITROS K+ SLIDE LOT 4102-1126-7783 ON A VITROS 350 CHEMISTRY SYSTEM. PATIENT SAMPLE VITROS K+ RESULT 4.2 MMOL/L VS. EXPECTED RESULT OF 6.0 MMOL/L. 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 K+ RESULT WAS NOT REPORTED OUT OF THE LABORATORY. THE CUSTOMER STATED NO TREATMENT WAS ALTERED, INITIATED OR STOPPED BASED ON THE REPORTED VITROS K+ RESULTS AND THERE WAS 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 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19690211 ↗
• MalfunctionMay 2, 2024Low Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED VITROS POTASSIUM (K+) RESULTS WERE OBTAINED FROM A SINGLE LEVEL OF VITROS PERFORMANCE VERIFIER (PV) II LOT P9966, USING VITROS K+ SLIDE LOT 4102-1116-4931 ON A VITROS XT3400 INTEGRATED SYSTEM. VITROS PV II P9966 K+ RESULTS OF 4.86 4.94 AND 4.74 MMOL/L VS. THE EXPECTED RESULT OF 5.72 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. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBERS (B)(4) AND REPORTABILITY ASSESSMENT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19229025 ↗
• MalfunctionMar 18, 2024High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A NON-REPRODUCIBLE, HIGHER THAN EXPECTED POTASSIUM (K+) RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE PROCESSED USING VITROS CHEMISTRY PRODUCTS K+ SLIDES LOT 4102-1127-8062 ON A VITROS XT 7600 INTEGRATED SYSTEM. PATIENT SAMPLE RESULT OF >14.00 MMOL/L VS THE EXPECTED RESULT OF 2.65 MMOL/L BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE NON-REPRODUCIBLE, HIGHER THAN EXPECTED VITROS K+ RESULT 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 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18921206 ↗
• MalfunctionFeb 23, 2024High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A NON-REPRODUCIBLE, HIGHER THAN EXPECTED POTASSIUM (K+) RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE PROCESSED USING VITROS CHEMISTRY PRODUCTS K+ SLIDES LOT 4102-1126-7817 ON A VITROS XT 7600 INTEGRATED SYSTEM. PATIENT SAMPLE RESULT OF >14.00 MMOL/L VS THE EXPECTED RESULT OF 2.87 MMOL/L BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE NON-REPRODUCIBLE, HIGHER THAN EXPECTED VITROS K+ RESULT 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 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18773020 ↗
• MalfunctionFeb 1, 2024Low Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED VITROS POTASSIUM (K+) RESULTS WERE OBTAINED FROM VITROS PERFORMANCE VERIFIER II (PV II) FLUID USING VITROS K+ REAGENT LOT 4102-1126-7830 ON A VITROS 350 CHEMISTRY SYSTEM. VITROS K+ LOT 4102-1126-7830 VITROS PV II FLUID LOT P9966 RESULTS OF 2.71, 3.03, 2.12, 3.87, 4.11, 2.35, 2.23, 4.18, 1.90, 2.26, 2.50, 2.40, 4.60, 3.20, AND 2.70 VERSUS THE EXPECTED RESULT OF 5.72 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 LOWER THAN EXPECTED VITROS K+ RESULTS WERE OBTAINED ON A VITROS PERFORMANCE VERIFIER II FLUID. THERE WAS NO REPORT OF AFFECTED PATIENT SAMPLES. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER SIX OF FIFTEEN MDRS FOR THIS EVENT. FIFTEEN 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS FIFTEEN 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 18626778 ↗
• MalfunctionFeb 1, 2024Low Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED VITROS POTASSIUM (K+) RESULTS WERE OBTAINED FROM VITROS PERFORMANCE VERIFIER II (PV II) FLUID USING VITROS K+ REAGENT LOT 4102-1126-7830 ON A VITROS 350 CHEMISTRY SYSTEM. VITROS K+ LOT 4102-1126-7830 VITROS PV II FLUID LOT P9966 RESULTS OF 2.71, 3.03, 2.12, 3.87, 4.11, 2.35, 2.23, 4.18, 1.90, 2.26, 2.50, 2.40, 4.60, 3.20, AND 2.70 VERSUS THE EXPECTED RESULT OF 5.72 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 LOWER THAN EXPECTED VITROS K+ RESULTS WERE OBTAINED ON A VITROS PERFORMANCE VERIFIER II FLUID. THERE WAS NO REPORT OF AFFECTED PATIENT SAMPLES. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER NINE OF FIFTEEN MDRS FOR THIS EVENT. FIFTEEN 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS FIFTEEN 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 18626752 ↗
• MalfunctionFeb 1, 2024Low Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED VITROS POTASSIUM (K+) RESULTS WERE OBTAINED FROM VITROS PERFORMANCE VERIFIER II (PV II) FLUID USING VITROS K+ REAGENT LOT 4102-1126-7830 ON A VITROS 350 CHEMISTRY SYSTEM. VITROS K+ LOT 4102-1126-7830 VITROS PV II FLUID LOT P9966 RESULTS OF 2.71, 3.03, 2.12, 3.87, 4.11, 2.35, 2.23, 4.18, 1.90, 2.26, 2.50, 2.40, 4.60, 3.20, AND 2.70 VERSUS THE EXPECTED RESULT OF 5.72 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 LOWER THAN EXPECTED VITROS K+ RESULTS WERE OBTAINED ON A VITROS PERFORMANCE VERIFIER II FLUID. THERE WAS NO REPORT OF AFFECTED PATIENT SAMPLES. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER FOURTEEN OF FIFTEEN MDRS FOR THIS EVENT. FIFTEEN 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS FIFTEEN 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 18626713 ↗
• MalfunctionFeb 1, 2024Low Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED VITROS POTASSIUM (K+) RESULTS WERE OBTAINED FROM VITROS PERFORMANCE VERIFIER II (PV II) FLUID USING VITROS K+ REAGENT LOT 4102-1126-7830 ON A VITROS 350 CHEMISTRY SYSTEM. VITROS K+ LOT 4102-1126-7830 VITROS PV II FLUID LOT P9966 RESULTS OF 2.71, 3.03, 2.12, 3.87, 4.11, 2.35, 2.23, 4.18, 1.90, 2.26, 2.50, 2.40, 4.60, 3.20, AND 2.70 VERSUS THE EXPECTED RESULT OF 5.72 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 LOWER THAN EXPECTED VITROS K+ RESULTS WERE OBTAINED ON A VITROS PERFORMANCE VERIFIER II FLUID. THERE WAS NO REPORT OF AFFECTED PATIENT SAMPLES. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER ELEVEN OF FIFTEEN MDRS FOR THIS EVENT. FIFTEEN 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS FIFTEEN 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 18626689 ↗
• MalfunctionFeb 1, 2024Low Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED VITROS POTASSIUM (K+) RESULTS WERE OBTAINED FROM VITROS PERFORMANCE VERIFIER II (PV II) FLUID USING VITROS K+ REAGENT LOT 4102-1126-7830 ON A VITROS 350 CHEMISTRY SYSTEM. VITROS K+ LOT 4102-1126-7830 VITROS PV II FLUID LOT P9966 RESULTS OF 2.71, 3.03, 2.12, 3.87, 4.11, 2.35, 2.23, 4.18, 1.90, 2.26, 2.50, 2.40, 4.60, 3.20, AND 2.70 VERSUS THE EXPECTED RESULT OF 5.72 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 LOWER THAN EXPECTED VITROS K+ RESULTS WERE OBTAINED ON A VITROS PERFORMANCE VERIFIER II FLUID. THERE WAS NO REPORT OF AFFECTED PATIENT SAMPLES. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER TWELVE OF FIFTEEN MDRS FOR THIS EVENT. FIFTEEN 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS FIFTEEN 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 18626664 ↗
• MalfunctionFeb 1, 2024Low Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED VITROS POTASSIUM (K+) RESULTS WERE OBTAINED FROM VITROS PERFORMANCE VERIFIER II (PV II) FLUID USING VITROS K+ REAGENT LOT 4102-1126-7830 ON A VITROS 350 CHEMISTRY SYSTEM. VITROS K+ LOT 4102-1126-7830 VITROS PV II FLUID LOT P9966 RESULTS OF 2.71, 3.03, 2.12, 3.87, 4.11, 2.35, 2.23, 4.18, 1.90, 2.26, 2.50, 2.40, 4.60, 3.20, AND 2.70 VERSUS THE EXPECTED RESULT OF 5.72 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 LOWER THAN EXPECTED VITROS K+ RESULTS WERE OBTAINED ON A VITROS PERFORMANCE VERIFIER II FLUID. THERE WAS NO REPORT OF AFFECTED PATIENT SAMPLES. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER EIGHT OF FIFTEEN MDRS FOR THIS EVENT. FIFTEEN 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS FIFTEEN 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 18626634 ↗
• MalfunctionFeb 1, 2024Low Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED VITROS POTASSIUM (K+) RESULTS WERE OBTAINED FROM VITROS PERFORMANCE VERIFIER II (PV II) FLUID USING VITROS K+ REAGENT LOT 4102-1126-7830 ON A VITROS 350 CHEMISTRY SYSTEM. VITROS K+ LOT 4102-1126-7830 VITROS PV II FLUID LOT P9966 RESULTS OF 2.71, 3.03, 2.12, 3.87, 4.11, 2.35, 2.23, 4.18, 1.90, 2.26, 2.50, 2.40, 4.60, 3.20, AND 2.70 VERSUS THE EXPECTED RESULT OF 5.72 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 LOWER THAN EXPECTED VITROS K+ RESULTS WERE OBTAINED ON A VITROS PERFORMANCE VERIFIER II FLUID. THERE WAS NO REPORT OF AFFECTED PATIENT SAMPLES. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER FOUR OF FIFTEEN MDRS FOR THIS EVENT. FIFTEEN 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS FIFTEEN 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 18626594 ↗
• MalfunctionFeb 1, 2024Low Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED VITROS POTASSIUM (K+) RESULTS WERE OBTAINED FROM VITROS PERFORMANCE VERIFIER II (PV II) FLUID USING VITROS K+ REAGENT LOT 4102-1126-7830 ON A VITROS 350 CHEMISTRY SYSTEM. VITROS K+ LOT 4102-1126-7830 VITROS PV II FLUID LOT P9966 RESULTS OF 2.71, 3.03, 2.12, 3.87, 4.11, 2.35, 2.23, 4.18, 1.90, 2.26, 2.50, 2.40, 4.60, 3.20, AND 2.70 VERSUS THE EXPECTED RESULT OF 5.72 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 LOWER THAN EXPECTED VITROS K+ RESULTS WERE OBTAINED ON A VITROS PERFORMANCE VERIFIER II FLUID. THERE WAS NO REPORT OF AFFECTED PATIENT SAMPLES. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER TWO OF FIFTEEN MDRS FOR THIS EVENT. FIFTEEN 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS FIFTEEN 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 18626541 ↗
• MalfunctionFeb 1, 2024Low Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED VITROS POTASSIUM (K+) RESULTS WERE OBTAINED FROM VITROS PERFORMANCE VERIFIER II (PV II) FLUID USING VITROS K+ REAGENT LOT 4102-1126-7830 ON A VITROS 350 CHEMISTRY SYSTEM. VITROS K+ LOT 4102-1126-7830 VITROS PV II FLUID LOT P9966 RESULTS OF 2.71, 3.03, 2.12, 3.87, 4.11, 2.35, 2.23, 4.18, 1.90, 2.26, 2.50, 2.40, 4.60, 3.20, AND 2.70 VERSUS THE EXPECTED RESULT OF 5.72 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 LOWER THAN EXPECTED VITROS K+ RESULTS WERE OBTAINED ON A VITROS PERFORMANCE VERIFIER II FLUID. THERE WAS NO REPORT OF AFFECTED PATIENT SAMPLES. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER FIVE OF FIFTEEN MDRS FOR THIS EVENT. FIFTEEN 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS FIFTEEN 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 18626505 ↗
• MalfunctionFeb 1, 2024Low Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED VITROS POTASSIUM (K+) RESULTS WERE OBTAINED FROM VITROS PERFORMANCE VERIFIER II (PV II) FLUID USING VITROS K+ REAGENT LOT 4102-1126-7830 ON A VITROS 350 CHEMISTRY SYSTEM. VITROS K+ LOT 4102-1126-7830 VITROS PV II FLUID LOT P9966 RESULTS OF 2.71, 3.03, 2.12, 3.87, 4.11, 2.35, 2.23, 4.18, 1.90, 2.26, 2.50, 2.40, 4.60, 3.20, AND 2.70 VERSUS THE EXPECTED RESULT OF 5.72 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 LOWER THAN EXPECTED VITROS K+ RESULTS WERE OBTAINED ON A VITROS PERFORMANCE VERIFIER II FLUID. THERE WAS NO REPORT OF AFFECTED PATIENT SAMPLES. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER THREE OF FIFTEEN MDRS FOR THIS EVENT. FIFTEEN 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS FIFTEEN 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 18626477 ↗
• MalfunctionFeb 1, 2024Low Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED VITROS POTASSIUM (K+) RESULTS WERE OBTAINED FROM VITROS PERFORMANCE VERIFIER II (PV II) FLUID USING VITROS K+ REAGENT LOT 4102-1126-7830 ON A VITROS 350 CHEMISTRY SYSTEM. VITROS K+ LOT 4102-1126-7830 VITROS PV II FLUID LOT P9966 RESULTS OF 2.71, 3.03, 2.12, 3.87, 4.11, 2.35, 2.23, 4.18, 1.90, 2.26, 2.50, 2.40, 4.60, 3.20, AND 2.70 VERSUS THE EXPECTED RESULT OF 5.72 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 LOWER THAN EXPECTED VITROS K+ RESULTS WERE OBTAINED ON A VITROS PERFORMANCE VERIFIER II FLUID. THERE WAS NO REPORT OF AFFECTED PATIENT SAMPLES. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER FIFTEEN OF FIFTEEN MDRS FOR THIS EVENT. FIFTEEN 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS FIFTEEN 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 18626441 ↗
• MalfunctionFeb 1, 2024Low Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED VITROS POTASSIUM (K+) RESULTS WERE OBTAINED FROM VITROS PERFORMANCE VERIFIER II (PV II) FLUID USING VITROS K+ REAGENT LOT 4102-1126-7830 ON A VITROS 350 CHEMISTRY SYSTEM. VITROS K+ LOT 4102-1126-7830 VITROS PV II FLUID LOT P9966 RESULTS OF 2.71, 3.03, 2.12, 3.87, 4.11, 2.35, 2.23, 4.18, 1.90, 2.26, 2.50, 2.40, 4.60, 3.20, AND 2.70 VERSUS THE EXPECTED RESULT OF 5.72 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 LOWER THAN EXPECTED VITROS K+ RESULTS WERE OBTAINED ON A VITROS PERFORMANCE VERIFIER II FLUID. THERE WAS NO REPORT OF AFFECTED PATIENT SAMPLES. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER TEN OF FIFTEEN MDRS FOR THIS EVENT. FIFTEEN 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS FIFTEEN 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 18626400 ↗
• MalfunctionFeb 1, 2024Low Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED VITROS POTASSIUM (K+) RESULTS WERE OBTAINED FROM VITROS PERFORMANCE VERIFIER II (PV II) FLUID USING VITROS K+ REAGENT LOT 4102-1126-7830 ON A VITROS 350 CHEMISTRY SYSTEM. VITROS K+ LOT 4102-1126-7830 VITROS PV II FLUID LOT P9966 RESULTS OF 2.71, 3.03, 2.12, 3.87, 4.11, 2.35, 2.23, 4.18, 1.90, 2.26, 2.50, 2.40, 4.60, 3.20, AND 2.70 VERSUS THE EXPECTED RESULT OF 5.72 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 LOWER THAN EXPECTED VITROS K+ RESULTS WERE OBTAINED ON A VITROS PERFORMANCE VERIFIER II FLUID. THERE WAS NO REPORT OF AFFECTED PATIENT SAMPLES. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER SEVEN OF FIFTEEN MDRS FOR THIS EVENT. FIFTEEN 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS FIFTEEN 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 18626371 ↗
• MalfunctionFeb 1, 2024Low Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED VITROS POTASSIUM (K+) RESULTS WERE OBTAINED FROM VITROS PERFORMANCE VERIFIER II (PV II) FLUID USING VITROS K+ REAGENT LOT 4102-1126-7830 ON A VITROS 350 CHEMISTRY SYSTEM. VITROS K+ LOT 4102-1126-7830 VITROS PV II FLUID LOT P9966 RESULTS OF 2.71, 3.03, 2.12, 3.87, 4.11, 2.35, 2.23, 4.18, 1.90, 2.26, 2.50, 2.40, 4.60, 3.20, AND 2.70 VERSUS THE EXPECTED RESULT OF 5.72 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 LOWER THAN EXPECTED VITROS K+ RESULTS WERE OBTAINED ON A VITROS PERFORMANCE VERIFIER II FLUID. THERE WAS NO REPORT OF AFFECTED PATIENT SAMPLES. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER THIRTEEN OF FIFTEEN MDRS FOR THIS EVENT. FIFTEEN 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS FIFTEEN 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 18626338 ↗
• MalfunctionFeb 1, 2024Low Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED VITROS POTASSIUM (K+) RESULTS WERE OBTAINED FROM VITROS PERFORMANCE VERIFIER II (PV II) FLUID USING VITROS K+ REAGENT LOT 4102-1126-7830 ON A VITROS 350 CHEMISTRY SYSTEM. VITROS K+ LOT 4102-1126-7830 VITROS PV II FLUID LOT P9966 RESULTS OF 2.71, 3.03, 2.12, 3.87, 4.11, 2.35, 2.23, 4.18, 1.90, 2.26, 2.50, 2.40, 4.60, 3.20, AND 2.70 VERSUS THE EXPECTED RESULT OF 5.72 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 LOWER THAN EXPECTED VITROS K+ RESULTS WERE OBTAINED ON A VITROS PERFORMANCE VERIFIER II FLUID. THERE WAS NO REPORT OF AFFECTED PATIENT SAMPLES. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER ONE OF FIFTEEN MDRS FOR THIS EVENT. FIFTEEN 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS FIFTEEN 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 18625878 ↗
• MalfunctionJan 16, 2024High Test Results; High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A HIGHER THAN EXPECTED VITROS POTASSIUM (K+) RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE TESTED ON A VITROS XT 7600 INTEGRATED SYSTEM. PATIENT SAMPLE K+ RESULT OF >14 MMOL/L VS. THE REPEAT RESULT OF 2.9 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 K+ RESULT WAS NOT REPORTED OUTSIDE OF 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 18521823 ↗
• MalfunctionOct 31, 2023High Test Results; High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A HIGHER THAN EXPECTED POTASSIUM (K+) RESULT WAS OBTAINED FROM A QUALITY CONTROL FLUID USING VITROS CHEMISTRY PRODUCTS K+ SLIDES LOT 4102-1101-0944 ON A VITROS XT7600 INTEGRATED SYSTEM. NON-VITROS MAS OMNI-CORE LOT 25111A RESULT OF >14.0 MMOL/L VERSUS THE EXPECTED RESULT OF 2.67 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 K+ RESULT WAS OBTAINED FROM A NON-PATIENT FLUID AND WAS NOT REPORTED FROM THE LABORATORY. 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 603765.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18042298 ↗
• MalfunctionSep 13, 2023Low Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED VITROS POTASSIUM (K+) RESULTS WERE OBTAINED FROM A SINGLE LEVEL OF VITROS PERFORMANCE VERIFIER (PV) II, LOT P9966, TESTED ON A VITROS 4600 CHEMISTRY SYSTEM. VITROS K+ PVII LOT P9966 RESULTS OF 3.46 AND 3.74 MMOL/L VERSUS THE BASELINE MEAN RESULT OF 5.707 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 LOWER THAN EXPECTED RESULTS WERE OBTAINED FROM A NON-PATIENT QUALITY CONTROL FLUID. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER TWO OF TWO MDR¿S 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 B4.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17736821 ↗
• MalfunctionSep 13, 2023Low Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED VITROS POTASSIUM (K+) RESULTS WERE OBTAINED FROM A SINGLE LEVEL OF VITROS PERFORMANCE VERIFIER (PV) II, LOT P9966, TESTED ON A VITROS 4600 CHEMISTRY SYSTEM. VITROS K+ PVII LOT P9966 RESULTS OF 3.46 AND 3.74 MMOL/L VERSUS THE BASELINE MEAN RESULT OF 5.707 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 LOWER THAN EXPECTED RESULTS WERE OBTAINED FROM A NON-PATIENT QUALITY CONTROL FLUID. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER ONE OF TWO MDR¿S 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 17736768 ↗