VITROS 1721869Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10758750009602), received between Mar 15, 2023 and Mar 2, 2026 — classified as 17 malfunctions.

The most frequently reported specific device problem is “High Test Results” (16 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 16, 2026.

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 2, 2026High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A HIGHER-THAN-EXPECTED RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE USING VITROS AMMONIA (AMON) SLIDE LOT: 1020-0268-5934 ON A VITROS 4600 CHEMISTRY SYSTEM. PATIENT SAMPLE VITROS AMON RESULT OF 182.7 UMOL/L VS. THE EXPECTED RESULT OF 28.2 UMOL/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 AMON RESULT WAS NOT REPORTED OUTSIDE THE LABORATORY AND THERE WAS NO ALLEGATION OF PATIENT HARM. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24482889 ↗
• MalfunctionFeb 4, 2026High 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 VITROS AMMONIA (AMON) RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE PROCESSED USING VITROS CHEMISTRY PRODUCTS AMON SLIDES LOT 1020-0268-5934 ON A VITROS 5600 INTEGRATED SYSTEM. PATIENT SAMPLE VITROS AMON RESULT OF 115.0 UMOL/L VERSUS AN EXPECTED RESULT OF 6.0 UMOL/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 AMON RESULT WAS NOT REPORTED OUT OF THE LABORATORY. THERE HAVE BEEN NO REPORTED ALLEGATIONS 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 24261192 ↗
• MalfunctionAug 28, 2024Low Test Results; Low Test Results

  THE INVESTIGATION DETERMINED THAT A LOWER THAN EXPECTED VITROS AMMONIA (AMON) RESULT WAS OBTAINED FROM A CAP PROFICIENCY FLUID PROCESSED USING VITROS CHEMISTRY PRODUCTS AMON SLIDES LOT 1020-0265-9321 ON A VITROS XT 7600 INTEGRATED SYSTEM. CHM-07 AMON RESULT OF 101 UMOL/L VERSUS AN EXPECTED RESULT OF 181 UMOL/L BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THE RESULTS WERE TO RECUR UNDETECTED. THE LOWER THAN EXPECTED VITROS AMON RESULT WAS GENERATED FROM A NON-PATIENT FLUID; HOWEVER, THE INVESTIGATION CANNOT CONCLUDE THAT PATIENT SAMPLE RESULTS WOULD NOT BE AFFECTED IF THE EVENT WERE TO RECUR UNDETECTED. THERE WERE NO ALLEGATIONS OF PATIENT HARM AS A RESULT OF THE EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER (B)(4) AND REPORTABILITY ASSESSMENT RA607130.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20089067 ↗
• MalfunctionSep 15, 2023High Test Results; High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED VITROS AMMONIA (AMON) RESULTS WERE OBTAINED FROM CAP PROFICIENCY FLUIDS PROCESSED USING VITROS CHEMISTRY PRODUCTS AMON SLIDES ON TWO DIFFERENT VITROS 5600 INTEGRATED SYSTEMS. FOR (B)(6) 2022 ON J1: CHM-06 RESULT OF 437 UMOL/L VS AN EXPECTED RESULT OF 312.9 UMOL/L CHM-07; RESULT OF 290 UMOL/L VS AN EXPECTED RESULT OF 215.9 UMOL/L CHM-08; RESULT OF 299 UMOL/L VS AN EXPECTED RESULT OF 219.6 UMOL/L CHM-09; RESULT OF 464 UMOL/L VS AN EXPECTED RESULT OF 334.1 UMOL/L CHM-10; RESULT OF 284 UMOL/L VS AN EXPECTED RESULT OF 215.9 UMOL/L. FOR (B)(6) 2022 ON J1: CHM-11 RESULT OF 394 UMOL/L VS AN EXPECTED RESULT OF 309.7 UMOL/L CHM-12; RESULT OF 577 UMOL/L VS AN EXPECTED RESULT OF 452.2 UMOL/L CHM-13; RESULT OF 446 UMOL/L VS AN EXPECTED RESULT OF 345.2 UMOL/L CHM-14; RESULT OF 188 UMOL/L VS AN EXPECTED RESULT OF 156.0 UMOL/L CHM-15 RESULT OF 424 UMOL/L VS AN EXPECTED RESULT OF 339.3 UMOL/L. FOR (B)(6) 2023 ON J2: CHM-02 RESULT OF 443 UMOL/L VS AN EXPECTED RESULT OF 368.0 UMOL/L CHM-04; RESULT OF 375 UMOL/L VS AN EXPECTED RESULT OF 312.5 UMOL/L. BIASED RESULTS OF THE MAGNITUD

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17760240 ↗
• MalfunctionSep 15, 2023High Test Results; High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED VITROS AMMONIA (AMON) RESULTS WERE OBTAINED FROM CAP PROFICIENCY FLUIDS PROCESSED USING VITROS CHEMISTRY PRODUCTS AMON SLIDES ON TWO DIFFERENT VITROS 5600 INTEGRATED SYSTEMS. FOR (B)(6) 2022 ON J1: CHM-06 RESULT OF 437 UMOL/L VS AN EXPECTED RESULT OF 312.9 UMOL/L CHM-07 RESULT OF 290 UMOL/L VS AN EXPECTED RESULT OF 215.9 UMOL/L CHM-08 RESULT OF 299 UMOL/L VS AN EXPECTED RESULT OF 219.6 UMOL/L CHM-09 RESULT OF 464 UMOL/L VS AN EXPECTED RESULT OF 334.1 UMOL/L CHM-10 RESULT OF 284 UMOL/L VS AN EXPECTED RESULT OF 215.9 UMOL/L FOR (B)(6) 2022 ON J1: CHM-11 RESULT OF 394 UMOL/L VS AN EXPECTED RESULT OF 309.7 UMOL/L CHM-12 RESULT OF 577 UMOL/L VS AN EXPECTED RESULT OF 452.2 UMOL/L CHM-13 RESULT OF 446 UMOL/L VS AN EXPECTED RESULT OF 345.2 UMOL/L CHM-14 RESULT OF 188 UMOL/L VS AN EXPECTED RESULT OF 156.0 UMOL/L CHM-15 RESULT OF 424 UMOL/L VS AN EXPECTED RESULT OF 339.3 UMOL/L FOR (B)(6) 2023 ON J2: CHM-02 RESULT OF 443 UMOL/L VS AN EXPECTED RESULT OF 368.0 UMOL/L CHM-04 RESULT OF 375 UMOL/L VS AN EXPECTED RESULT OF 312.5 UMOL/L BIASED RESULTS OF THE MAGNITUDE AND DIREC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17760092 ↗
• MalfunctionSep 15, 2023High Test Results; High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED VITROS AMMONIA (AMON) RESULTS WERE OBTAINED FROM CAP PROFICIENCY FLUIDS PROCESSED USING VITROS CHEMISTRY PRODUCTS AMON SLIDES ON TWO DIFFERENT VITROS 5600 INTEGRATED SYSTEMS. FOR ON (B)(6) 2022 ON J1: CHM-06 RESULT OF 437 UMOL/L VS AN EXPECTED RESULT OF 312.9 UMOL/L CHM-07 RESULT OF 290 UMOL/L VS AN EXPECTED RESULT OF 215.9 UMOL/L CHM-08 RESULT OF 299 UMOL/L VS AN EXPECTED RESULT OF 219.6 UMOL/L CHM-09 RESULT OF 464 UMOL/L VS AN EXPECTED RESULT OF 334.1 UMOL/L CHM-10 RESULT OF 284 UMOL/L VS AN EXPECTED RESULT OF 215.9 UMOL/L FOR ON (B)(6) 2022 ON J1: CHM-11 RESULT OF 394 UMOL/L VS AN EXPECTED RESULT OF 309.7 UMOL/L CHM-12 RESULT OF 577 UMOL/L VS AN EXPECTED RESULT OF 452.2 UMOL/L CHM-13 RESULT OF 446 UMOL/L VS AN EXPECTED RESULT OF 345.2 UMOL/L CHM-14 RESULT OF 188 UMOL/L VS AN EXPECTED RESULT OF 156.0 UMOL/L CHM-15 RESULT OF 424 UMOL/L VS AN EXPECTED RESULT OF 339.3 UMOL/L FOR ON (B)(6) 2023 ON J2: CHM-02 RESULT OF 443 UMOL/L VS AN EXPECTED RESULT OF 368.0 UMOL/L CHM-04 RESULT OF 375 UMOL/L VS AN EXPECTED RESULT OF 312.5 UMOL/L BIASED RESULTS OF THE MAGNITUDE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17759931 ↗
• MalfunctionSep 15, 2023High Test Results; High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED VITROS AMMONIA (AMON) RESULTS WERE OBTAINED FROM CAP PROFICIENCY FLUIDS PROCESSED USING VITROS CHEMISTRY PRODUCTS AMON SLIDES ON TWO DIFFERENT VITROS 5600 INTEGRATED SYSTEMS. FOR (B)(6)2022 ON J1: CHM-06 RESULT OF 437 UMOL/L VS AN EXPECTED RESULT OF 312.9 UMOL/L CHM-07 RESULT OF 290 UMOL/L VS AN EXPECTED RESULT OF 215.9 UMOL/L CHM-08 RESULT OF 299 UMOL/L VS AN EXPECTED RESULT OF 219.6 UMOL/L CHM-09 RESULT OF 464 UMOL/L VS AN EXPECTED RESULT OF 334.1 UMOL/L CHM-10 RESULT OF 284 UMOL/L VS AN EXPECTED RESULT OF 215.9 UMOL/L FOR 28 OCTOBER 2022 ON J1: CHM-11 RESULT OF 394 UMOL/L VS AN EXPECTED RESULT OF 309.7 UMOL/L CHM-12 RESULT OF 577 UMOL/L VS AN EXPECTED RESULT OF 452.2 UMOL/L CHM-13 RESULT OF 446 UMOL/L VS AN EXPECTED RESULT OF 345.2 UMOL/L CHM-14 RESULT OF 188 UMOL/L VS AN EXPECTED RESULT OF 156.0 UMOL/L CHM-15 RESULT OF 424 UMOL/L VS AN EXPECTED RESULT OF 339.3 UMOL/L FOR 19 APRIL 2023 ON J2: CHM-02 RESULT OF 443 UMOL/L VS AN EXPECTED RESULT OF 368.0 UMOL/L CHM-04 RESULT OF 375 UMOL/L VS AN EXPECTED RESULT OF 312.5 UMOL/L BIASED RESULTS OF THE MAGNITUDE AND

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17759783 ↗
• MalfunctionSep 15, 2023High Test Results; High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED VITROS AMMONIA (AMON) RESULTS WERE OBTAINED FROM CAP PROFICIENCY FLUIDS PROCESSED USING VITROS CHEMISTRY PRODUCTS AMON SLIDES ON TWO DIFFERENT VITROS 5600 INTEGRATED SYSTEMS. FOR 08 JUNE 2022 ON J1: CHM-06 RESULT OF 437 UMOL/L VS AN EXPECTED RESULT OF 312.9 UMOL/L CHM-07 RESULT OF 290 UMOL/L VS AN EXPECTED RESULT OF 215.9 UMOL/L CHM-08 RESULT OF 299 UMOL/L VS AN EXPECTED RESULT OF 219.6 UMOL/L CHM-09 RESULT OF 464 UMOL/L VS AN EXPECTED RESULT OF 334.1 UMOL/L CHM-10 RESULT OF 284 UMOL/L VS AN EXPECTED RESULT OF 215.9 UMOL/L FOR 28 OCTOBER 2022 ON J1: CHM-11 RESULT OF 394 UMOL/L VS AN EXPECTED RESULT OF 309.7 UMOL/L CHM-12 RESULT OF 577 UMOL/L VS AN EXPECTED RESULT OF 452.2 UMOL/L CHM-13 RESULT OF 446 UMOL/L VS AN EXPECTED RESULT OF 345.2 UMOL/L CHM-14 RESULT OF 188 UMOL/L VS AN EXPECTED RESULT OF 156.0 UMOL/L CHM-15 RESULT OF 424 UMOL/L VS AN EXPECTED RESULT OF 339.3 UMOL/L FOR 19 APRIL 2023 ON J2: CHM-02 RESULT OF 443 UMOL/L VS AN EXPECTED RESULT OF 368.0 UMOL/L CHM-04 RESULT OF 375 UMOL/L VS AN EXPECTED RESULT OF 312.5 UMOL/L BIASED RESULTS OF THE MAGNITUDE AN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17759571 ↗
• MalfunctionSep 15, 2023High Test Results; High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED VITROS AMMONIA (AMON) RESULTS WERE OBTAINED FROM CAP PROFICIENCY FLUIDS PROCESSED USING VITROS CHEMISTRY PRODUCTS AMON SLIDES ON TWO DIFFERENT VITROS 5600 INTEGRATED SYSTEMS. FOR 08 JUNE 2022 ON J1: CHM-06 RESULT OF 437 UMOL/L VS AN EXPECTED RESULT OF 312.9 UMOL/L CHM-07 RESULT OF 290 UMOL/L VS AN EXPECTED RESULT OF 215.9 UMOL/L CHM-08 RESULT OF 299 UMOL/L VS AN EXPECTED RESULT OF 219.6 UMOL/L CHM-09 RESULT OF 464 UMOL/L VS AN EXPECTED RESULT OF 334.1 UMOL/L CHM-10 RESULT OF 284 UMOL/L VS AN EXPECTED RESULT OF 215.9 UMOL/L FOR 28 OCTOBER 2022 ON J1: CHM-11 RESULT OF 394 UMOL/L VS AN EXPECTED RESULT OF 309.7 UMOL/L CHM-12 RESULT OF 577 UMOL/L VS AN EXPECTED RESULT OF 452.2 UMOL/L CHM-13 RESULT OF 446 UMOL/L VS AN EXPECTED RESULT OF 345.2 UMOL/L CHM-14 RESULT OF 188 UMOL/L VS AN EXPECTED RESULT OF 156.0 UMOL/L CHM-15 RESULT OF 424 UMOL/L VS AN EXPECTED RESULT OF 339.3 UMOL/L FOR 19 APRIL 2023 ON J2: CHM-02 RESULT OF 443 UMOL/L VS AN EXPECTED RESULT OF 368.0 UMOL/L CHM-04 RESULT OF 375 UMOL/L VS AN EXPECTED RESULT OF 312.5 UMOL/L BIASED RESULTS OF THE MAGNITUDE AN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17759545 ↗
• MalfunctionSep 15, 2023High Test Results; High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED VITROS AMMONIA (AMON) RESULTS WERE OBTAINED FROM CAP PROFICIENCY FLUIDS PROCESSED USING VITROS CHEMISTRY PRODUCTS AMON SLIDES ON TWO DIFFERENT VITROS 5600 INTEGRATED SYSTEMS. FOR 08 JUNE 2022 ON J1: CHM-06 RESULT OF 437 UMOL/L VS AN EXPECTED RESULT OF 312.9 UMOL/L CHM-07 RESULT OF 290 UMOL/L VS AN EXPECTED RESULT OF 215.9 UMOL/L CHM-08 RESULT OF 299 UMOL/L VS AN EXPECTED RESULT OF 219.6 UMOL/L CHM-09 RESULT OF 464 UMOL/L VS AN EXPECTED RESULT OF 334.1 UMOL/L CHM-10 RESULT OF 284 UMOL/L VS AN EXPECTED RESULT OF 215.9 UMOL/L FOR 28 OCTOBER 2022 ON J1: CHM-11 RESULT OF 394 UMOL/L VS AN EXPECTED RESULT OF 309.7 UMOL/L CHM-12 RESULT OF 577 UMOL/L VS AN EXPECTED RESULT OF 452.2 UMOL/L CHM-13 RESULT OF 446 UMOL/L VS AN EXPECTED RESULT OF 345.2 UMOL/L CHM-14 RESULT OF 188 UMOL/L VS AN EXPECTED RESULT OF 156.0 UMOL/L CHM-15 RESULT OF 424 UMOL/L VS AN EXPECTED RESULT OF 339.3 UMOL/L FOR 19 APRIL 2023 ON J2: CHM-02 RESULT OF 443 UMOL/L VS AN EXPECTED RESULT OF 368.0 UMOL/L CHM-04 RESULT OF 375 UMOL/L VS AN EXPECTED RESULT OF 312.5 UMOL/L BIASED RESULTS OF THE MAGNITUDE AN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17759504 ↗
• MalfunctionSep 15, 2023High Test Results; High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED VITROS AMMONIA (AMON) RESULTS WERE OBTAINED FROM CAP PROFICIENCY FLUIDS PROCESSED USING VITROS CHEMISTRY PRODUCTS AMON SLIDES ON TWO DIFFERENT VITROS 5600 INTEGRATED SYSTEMS. FOR ON (B)(6) 2022 J1: CHM-06 RESULT OF 437 UMOL/L VS AN EXPECTED RESULT OF 312.9 UMOL/L CHM-07 RESULT OF 290 UMOL/L VS AN EXPECTED RESULT OF 215.9 UMOL/L CHM-08 RESULT OF 299 UMOL/L VS AN EXPECTED RESULT OF 219.6 UMOL/L CHM-09 RESULT OF 464 UMOL/L VS AN EXPECTED RESULT OF 334.1 UMOL/L CHM-10 RESULT OF 284 UMOL/L VS AN EXPECTED RESULT OF 215.9 UMOL/L FOR ON (B)(6) 2022 J1: CHM-11 RESULT OF 394 UMOL/L VS AN EXPECTED RESULT OF 309.7 UMOL/L CHM-12 RESULT OF 577 UMOL/L VS AN EXPECTED RESULT OF 452.2 UMOL/L CHM-13 RESULT OF 446 UMOL/L VS AN EXPECTED RESULT OF 345.2 UMOL/L CHM-14 RESULT OF 188 UMOL/L VS AN EXPECTED RESULT OF 156.0 UMOL/L CHM-15 RESULT OF 424 UMOL/L VS AN EXPECTED RESULT OF 339.3 UMOL/L FOR ON (B)(6) 2023 J2: CHM-02 RESULT OF 443 UMOL/L VS AN EXPECTED RESULT OF 368.0 UMOL/L CHM-04 RESULT OF 375 UMOL/L VS AN EXPECTED RESULT OF 312.5 UMOL/L BIASED RESULTS OF THE MAGNITUDE AND DIREC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17759479 ↗
• MalfunctionSep 15, 2023High Test Results; High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED VITROS AMMONIA (AMON) RESULTS WERE OBTAINED FROM CAP PROFICIENCY FLUIDS PROCESSED USING VITROS CHEMISTRY PRODUCTS AMON SLIDES ON TWO DIFFERENT VITROS 5600 INTEGRATED SYSTEMS. FOR 08 JUNE 2022 ON J1: CHM-06 RESULT OF 437 UMOL/L VS AN EXPECTED RESULT OF 312.9 UMOL/L CHM-07 RESULT OF 290 UMOL/L VS AN EXPECTED RESULT OF 215.9 UMOL/L CHM-08 RESULT OF 299 UMOL/L VS AN EXPECTED RESULT OF 219.6 UMOL/L CHM-09 RESULT OF 464 UMOL/L VS AN EXPECTED RESULT OF 334.1 UMOL/L CHM-10 RESULT OF 284 UMOL/L VS AN EXPECTED RESULT OF 215.9 UMOL/L FOR 28 OCTOBER 2022 ON J1: CHM-11 RESULT OF 394 UMOL/L VS AN EXPECTED RESULT OF 309.7 UMOL/L CHM-12 RESULT OF 577 UMOL/L VS AN EXPECTED RESULT OF 452.2 UMOL/L CHM-13 RESULT OF 446 UMOL/L VS AN EXPECTED RESULT OF 345.2 UMOL/L CHM-14 RESULT OF 188 UMOL/L VS AN EXPECTED RESULT OF 156.0 UMOL/L CHM-15 RESULT OF 424 UMOL/L VS AN EXPECTED RESULT OF 339.3 UMOL/L FOR 19 APRIL 2023 ON J2: CHM-02 RESULT OF 443 UMOL/L VS AN EXPECTED RESULT OF 368.0 UMOL/L CHM-04 RESULT OF 375 UMOL/L VS AN EXPECTED RESULT OF 312.5 UMOL/L BIASED RESULTS OF THE MAGNITUDE AN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17759419 ↗
• MalfunctionSep 15, 2023High Test Results; High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED VITROS AMMONIA (AMON) RESULTS WERE OBTAINED FROM CAP PROFICIENCY FLUIDS PROCESSED USING VITROS CHEMISTRY PRODUCTS AMON SLIDES ON TWO DIFFERENT VITROS 5600 INTEGRATED SYSTEMS. FOR (B)(6) 2022 ON J1: CHM-06 RESULT OF 437 UMOL/L VS AN EXPECTED RESULT OF 312.9 UMOL/L CHM-07 RESULT OF 290 UMOL/L VS AN EXPECTED RESULT OF 215.9 UMOL/L CHM-08 RESULT OF 299 UMOL/L VS AN EXPECTED RESULT OF 219.6 UMOL/L CHM-09 RESULT OF 464 UMOL/L VS AN EXPECTED RESULT OF 334.1 UMOL/L CHM-10 RESULT OF 284 UMOL/L VS AN EXPECTED RESULT OF 215.9 UMOL/L FOR 28 (B)(6) 2022 ON J1: CHM-11 RESULT OF 394 UMOL/L VS AN EXPECTED RESULT OF 309.7 UMOL/L CHM-12 RESULT OF 577 UMOL/L VS AN EXPECTED RESULT OF 452.2 UMOL/L CHM-13 RESULT OF 446 UMOL/L VS AN EXPECTED RESULT OF 345.2 UMOL/L CHM-14 RESULT OF 188 UMOL/L VS AN EXPECTED RESULT OF 156.0 UMOL/L CHM-15 RESULT OF 424 UMOL/L VS AN EXPECTED RESULT OF 339.3 UMOL/L FOR (B)(6) 2023 ON J2: CHM-02 RESULT OF 443 UMOL/L VS AN EXPECTED RESULT OF 368.0 UMOL/L CHM-04 RESULT OF 375 UMOL/L VS AN EXPECTED RESULT OF 312.5 UMOL/L BIASED RESULTS OF THE MAGNITUDE AND D

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17759250 ↗
• MalfunctionSep 15, 2023High Test Results; High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED VITROS AMMONIA (AMON) RESULTS WERE OBTAINED FROM CAP PROFICIENCY FLUIDS PROCESSED USING VITROS CHEMISTRY PRODUCTS AMON SLIDES ON TWO DIFFERENT VITROS 5600 INTEGRATED SYSTEMS. FOR (B)(6) 2022 ON J1: CHM-06 RESULT OF 437 UMOL/L VS AN EXPECTED RESULT OF 312.9 UMOL/L CHM-07; RESULT OF 290 UMOL/L VS AN EXPECTED RESULT OF 215.9 UMOL/L CHM-08. RESULT OF 299 UMOL/L VS AN EXPECTED RESULT OF 219.6 UMOL/L CHM-09. RESULT OF 464 UMOL/L VS AN EXPECTED RESULT OF 334.1 UMOL/L CHM-10. RESULT OF 284 UMOL/L VS AN EXPECTED RESULT OF 215.9 UMOL/L. FOR (B)(6) 2022 ON J1: CHM-11 RESULT OF 394 UMOL/L VS AN EXPECTED RESULT OF 309.7 UMOL/L CHM-12; RESULT OF 577 UMOL/L VS AN EXPECTED RESULT OF 452.2 UMOL/L CHM-13; RESULT OF 446 UMOL/L VS AN EXPECTED RESULT OF 345.2 UMOL/L CHM-14; RESULT OF 188 UMOL/L VS AN EXPECTED RESULT OF 156.0 UMOL/L CHM-15; RESULT OF 424 UMOL/L VS AN EXPECTED RESULT OF 339.3 UMOL/L. FOR (B)(6) 2023 ON J2: CHM-02 RESULT OF 443 UMOL/L VS AN EXPECTED RESULT OF 368.0 UMOL/L CHM-04; RESULT OF 375 UMOL/L VS AN EXPECTED RESULT OF 312.5 UMOL/L. BIASED RESULTS OF THE MAGNITU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17758495 ↗
• MalfunctionSep 14, 2023High Test Results; High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED VITROS AMMONIA (AMON) RESULTS WERE OBTAINED FROM CAP PROFICIENCY FLUIDS PROCESSED USING VITROS CHEMISTRY PRODUCTS AMON SLIDES ON TWO DIFFERENT VITROS 5600 INTEGRATED SYSTEMS. FOR (B)(6) 2022 ON J1: CHM-06 RESULT OF 437 UMOL/L VS AN EXPECTED RESULT OF 312.9 UMOL/L CHM-07; RESULT OF 290 UMOL/L VS AN EXPECTED RESULT OF 215.9 UMOL/L CHM-08. RESULT OF 299 UMOL/L VS AN EXPECTED RESULT OF 219.6 UMOL/L CHM-09. RESULT OF 464 UMOL/L VS AN EXPECTED RESULT OF 334.1 UMOL/L CHM-10. RESULT OF 284 UMOL/L VS AN EXPECTED RESULT OF 215.9 UMOL/L. FOR (B)(6) 2022 ON J1: CHM-11 RESULT OF 394 UMOL/L VS AN EXPECTED RESULT OF 309.7 UMOL/L CHM-12; RESULT OF 577 UMOL/L VS AN EXPECTED RESULT OF 452.2 UMOL/L CHM-13; RESULT OF 446 UMOL/L VS AN EXPECTED RESULT OF 345.2 UMOL/L CHM-14; RESULT OF 188 UMOL/L VS AN EXPECTED RESULT OF 156.0 UMOL/L CHM-15; RESULT OF 424 UMOL/L VS AN EXPECTED RESULT OF 339.3 UMOL/L. FOR (B)(6) 2023 ON J2: CHM-02 RESULT OF 443 UMOL/L VS AN EXPECTED RESULT OF 368.0 UMOL/L CHM-04; RESULT OF 375 UMOL/L VS AN EXPECTED RESULT OF 312.5 UMOL/L. BIASED RESULTS OF THE MAGNITU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17747677 ↗
• MalfunctionMar 15, 2023High 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 HIGHER THAN EXPECTED VITROS AMMONIA (AMON) RESULTS WERE OBTAINED FROM A SINGLE PATIENT SAMPLE AND A LOWER THAN EXPECTED QUALITY CONTROL RESULT WAS OBTAINED FROM A VITROS LIQUID PERFORMANCE VERIFIER (LPV) PROCESSED USING VITROS CHEMISTRY PRODUCTS AMON SLIDES LOT 1019-0259-9814 ON TWO DIFFERENT VITROS XT 7600 INTEGRATED SYSTEMS. ANALYZER 1: PATIENT SAMPLE RESULT OF 125 UMOL/L VERSUS AN EXPECTED RESULT OF 90 UMOL/L. ANALYZER 2: PATIENT SAMPLE RESULTS OF 239, 235, 255, 251, 257 AND 275 UMOL/L VERSUS AN EXPECTED RESULT OF 90 UMOL/L VITROS LPV II LOT X9323 RESULT OF 153.5 UMOL/L VERSUS AN EXPECTED RESULT OF 195.69 UMOL/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 AMON RESULT WAS FROM A NON-PATIENT FLUID. THE HIGHER THAN EXPECTED VITROS AMON PATIENT SAMPLE RESULTS WERE NOT REPORTED OUT OF THE LABORATORY AND NO TREATMENT WAS INITIATED, ALTERED OR STOPPED BASED ON ANY VITROS RESULTS. ORTHO WAS NOT MADE AWARE OF ANY ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16544606 ↗
• MalfunctionMar 15, 2023High Test Results; Low Test Results; High Test Results; Low Test Results

  HOLD NB II A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED VITROS AMMONIA (AMON) RESULTS WERE OBTAINED FROM A SINGLE PATIENT SAMPLE AND A LOWER THAN EXPECTED QUALITY CONTROL RESULT WAS OBTAINED FROM A VITROS LIQUID PERFORMANCE VERIFIER (LPV) PROCESSED USING VITROS CHEMISTRY PRODUCTS AMON SLIDES LOT: 1019-0259-9814 ON TWO DIFFERENT VITROS XT 7600 INTEGRATED SYSTEMS. ANALYZER 1: PATIENT SAMPLE RESULT OF 125 UMOL/L VERSUS AN EXPECTED RESULT OF 90 UMOL/L ANALYZER 2: PATIENT SAMPLE RESULTS OF 239, 235, 255, 251, 257 AND 275 UMOL/L VERSUS AN EXPECTED RESULT OF 90 UMOL/L VITROS LPV II LOT X9323 RESULT OF 153.5 UMOL/L VERSUS AN EXPECTED RESULT OF 195.69 UMOL/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 AMON RESULT WAS FROM A NON-PATIENT FLUID. THE HIGHER THAN EXPECTED VITROS AMON PATIENT SAMPLE RESULTS WERE NOT REPORTED OUT OF THE LABORATORY AND NO TREATMENT WAS INITIATED, ALTERED OR STOPPED BASED ON ANY VITROS RESULTS. ORTHO WAS NOT MADE AWARE OF ANY ALLEGATION OF PATIENT HARM AS A RESULT OF THIS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16544605 ↗