VITROS 6192255Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10758750033300), received between Jan 11, 2023 and Feb 9, 2026 — classified as 18 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (13 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 9, 2026Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED NBNP2 RESULTS WERE OBTAINED WHEN A LEVEL 3 BIORAD QC FLUID WAS PROCESSED USING VITROS NBNP2 LOT 2200 AND LOT 2230 ON A VITROS 3600 IMMUNODIAGNOSTIC SYSTEM. BIORAD LOT 1003123 (LEVEL 3), VITROS NBNP2 LOT 2200 RESULTS OF 1217.34, 1163.83, 1173.65, 1212.79, 1211.16, 1167.65, 1155.88 AND 1160.77 PG/ML VERSUS THE BASELINE MEAN RESULT OF 1636.0 PG/ML BIORAD LOT 1003123 (LEVEL 3), VITROS NBNP2 LOT 2230 RESULTS OF 1189.34, 1155.1, 1162.1, 1129.16 AND 1091.87 PG/ML VERSUS THE BASELINE MEAN RESULT OF 1636.0 PG/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 VITROS NBNP2 RESULTS WERE OBTAINED WHEN THE CUSTOMER WAS PROCESSING NON-PATIENT FLUIDS. THERE HAS BEEN 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 NUMBERS (B)(4)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24290965 ↗
• MalfunctionFeb 9, 2026Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED NBNP2 RESULTS WERE OBTAINED WHEN A LEVEL 3 BIORAD QC FLUID WAS PROCESSED USING VITROS NBNP2 LOT 2200 AND LOT 2230 ON A VITROS 3600 IMMUNODIAGNOSTIC SYSTEM. BIORAD LOT 1003123 (LEVEL 3), VITROS NBNP2 LOT 2200 RESULTS OF 1217.34, 1163.83, 1173.65, 1212.79, 1211.16, 1167.65, 1155.88 AND 1160.77 PG/ML VERSUS THE BASELINE MEAN RESULT OF 1636.0 PG/ML BIORAD LOT 1003123 (LEVEL 3), VITROS NBNP2 LOT 2230 RESULTS OF 1189.34, 1155.1, 1162.1, 1129.16 AND 1091.87 PG/ML VERSUS THE BASELINE MEAN RESULT OF 1636.0 PG/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 VITROS NBNP2 RESULTS WERE OBTAINED WHEN THE CUSTOMER WAS PROCESSING NON-PATIENT FLUIDS. THERE HAS BEEN 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 NUMBERS (B)(4) AN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24290939 ↗
• MalfunctionFeb 9, 2026Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED NBNP2 RESULTS WERE OBTAINED WHEN A LEVEL 3 BIORAD QC FLUID WAS PROCESSED USING VITROS NBNP2 LOT 2200 AND LOT 2230 ON A VITROS 3600 IMMUNODIAGNOSTIC SYSTEM. BIORAD LOT 1003123 (LEVEL 3), VITROS NBNP2 LOT 2200 RESULTS OF 1217.34, 1163.83, 1173.65, 1212.79, 1211.16, 1167.65, 1155.88 AND 1160.77 PG/ML VERSUS THE BASELINE MEAN RESULT OF 1636.0 PG/ML BIORAD LOT 1003123 (LEVEL 3), VITROS NBNP2 LOT 2230 RESULTS OF 1189.34, 1155.1, 1162.1, 1129.16 AND 1091.87 PG/ML VERSUS THE BASELINE MEAN RESULT OF 1636.0 PG/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 VITROS NBNP2 RESULTS WERE OBTAINED WHEN THE CUSTOMER WAS PROCESSING NON-PATIENT FLUIDS. THERE HAS BEEN 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 NUMBERS (B)(4) AN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24290927 ↗
• MalfunctionJan 12, 2026Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED NT-PROBNP II (NBNP2) RESULTS WERE OBTAINED WHEN A LEVEL 2 BIORAD QC FLUID WAS PROCESSED USING VITROS NBNP2 LOT 0610 ON A VITROS XT7600 INTEGRATED SYSTEM. BIORAD 67712 (LEVEL 2) RESULTS OF 114.89, 116.89 AND 135.47 PG/ML VERSUS THE CUSTOMERS ESTABLISHED BASELINE MEAN VALUE OF 195 PG/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 VITROS NBNP2 RESULTS WERE OBTAINED WHEN THE CUSTOMER WAS PROCESSING A NON-PATIENT FLUID. HOWEVER, THE INVESTIGATION CANNOT RULE OUT THAT PATIENT SAMPLE RESULTS WOULD NOT BE AFFECTED IF THE EVENT WERE TO RECUR UNDETECTED. THERE HAS BEEN 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 613073.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24036240 ↗
• MalfunctionFeb 20, 2025Low Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED NT-PROBNP II (NTBNP II) RESULTS WERE OBTAINED WHEN PROCESSING NON-VITROS BIORAD LIQUICHEK CARDIAC MARKER PLUS QUALITY CONTROL (QC) FLUIDS LOT 1003100 ON A VITROS 5600 INTEGRATED SYSTEM. BIORAD LEVEL 2 RESULTS OF 117.0, 101.7, 97.8 AND 106.9 PG/ML VS EXPECTED RESULT OF 156.2 PG/ML BIORAD LEVEL 3 RESULTS OF 1782.0 PG/ML VS EXPECTED RESULT OF 2402.0 PG/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 VITROS NTBNP II RESULTS WERE OBTAINED WHEN PROCESSING NON-VITROS QC FLUIDS. THE CUSTOMER MADE NO INDICATION THAT ANY PATIENT SAMPLE RESULTS HAD BEEN AFFECTED, HOWEVER, ORTHO CANNOT CONCLUDE THAT PATIENT SAMPLES WERE NOT OR WOULD NOT BE AFFECTED IF THE EVENT WERE TO RECUR UNDETECTED. THERE WERE NO REPORTED ALLEGATIONS OF 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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21421559 ↗
• MalfunctionFeb 20, 2025Low Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED NT-PROBNP II (NTBNP II) RESULTS WERE OBTAINED WHEN PROCESSING NON-VITROS BIORAD LIQUICHEK CARDIAC MARKER PLUS QUALITY CONTROL (QC) FLUIDS LOT 1003100 ON A VITROS 5600 INTEGRATED SYSTEM. BIORAD LEVEL 2 RESULTS OF 117.0, 101.7, 97.8 AND 106.9 PG/ML VS EXPECTED RESULT OF 156.2 PG/ML BIORAD LEVEL 3 RESULTS OF 1782.0 PG/ML VS EXPECTED RESULT OF 2402.0 PG/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 VITROS NTBNP II RESULTS WERE OBTAINED WHEN PROCESSING NON-VITROS QC FLUIDS. THE CUSTOMER MADE NO INDICATION THAT ANY PATIENT SAMPLE RESULTS HAD BEEN AFFECTED, HOWEVER, ORTHO CANNOT CONCLUDE THAT PATIENT SAMPLES WERE NOT OR WOULD NOT BE AFFECTED IF THE EVENT WERE TO RECUR UNDETECTED. THERE WERE NO REPORTED ALLEGATIONS OF 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 DIAGNOSTI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21421470 ↗
• MalfunctionFeb 20, 2025Low Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED NT-PROBNP II (NTBNP II) RESULTS WERE OBTAINED WHEN PROCESSING NON-VITROS BIORAD LIQUICHEK CARDIAC MARKER PLUS QUALITY CONTROL (QC) FLUIDS LOT 1003100 ON A VITROS 5600 INTEGRATED SYSTEM. BIORAD LEVEL 2 RESULTS OF 117.0, 101.7, 97.8 AND 106.9 PG/ML VS EXPECTED RESULT OF 156.2 PG/ML BIORAD LEVEL 3 RESULTS OF 1782.0 PG/ML VS EXPECTED RESULT OF 2402.0 PG/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 VITROS NTBNP II RESULTS WERE OBTAINED WHEN PROCESSING NON-VITROS QC FLUIDS. THE CUSTOMER MADE NO INDICATION THAT ANY PATIENT SAMPLE RESULTS HAD BEEN AFFECTED, HOWEVER, ORTHO CANNOT CONCLUDE THAT PATIENT SAMPLES WERE NOT OR WOULD NOT BE AFFECTED IF THE EVENT WERE TO RECUR UNDETECTED. THERE WERE NO REPORTED ALLEGATIONS OF 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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21421264 ↗
• MalfunctionAug 28, 2024Low Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A LOWER THAN EXPECTED NT-PROBNP II (NBNP2) RESULT WAS OBTAINED WHEN A LEVEL 3 BIORAD QC FLUID WAS PROCESSED USING VITROS NBNP2 LOT 0260 ON A VITROS XT 7600 INTEGRATED SYSTEM. BIORAD 67703 RESULT OF 42.45 PG/ML VERSUS THE BASELINE MEAN RESULT OF 2500 PG/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 VITROS NBNP2 RESULT WAS OBTAINED WHEN THE CUSTOMER WAS PROCESSING A NON-PATIENT FLUID. THERE HAS BEEN 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 607157.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20089762 ↗
• MalfunctionJun 4, 2024Low Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT REPRODUCIBLE, LOWER THAN EXPECTED VITROS NT-PROBNP II (NBNP2) (LOT 0250) RESULTS WERE OBTAINED WHEN A VITROS NBNP2 HIGH RANGE VERIFIER (RV) FLUID (LOT 0510) WAS PROCESSED ON A VITROS XT7600 INTEGRATED SYSTEM. VITROS NBNP2 LOT 0510 HIGH RV RESULTS OF 11891.6, 11829.5, 11325.7, 11401.4 AND 11416.4 PG/ML VERSUS THE EXPECTED RESULT OF 28500 PG/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 VITROS NBNP2 RESULTS WERE OBTAINED WHEN THE CUSTOMER WAS PROCESSING A NON-PATIENT FLUID. THERE HAS BEEN 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 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19462137 ↗
• MalfunctionJun 4, 2024Low Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT REPRODUCIBLE, LOWER THAN EXPECTED VITROS NT-PROBNP II (NBNP2) (LOT 0250) RESULTS WERE OBTAINED WHEN A VITROS NBNP2 HIGH RANGE VERIFIER (RV) FLUID (LOT 0510) WAS PROCESSED ON A VITROS XT7600 INTEGRATED SYSTEM. VITROS NBNP2 LOT 0510 HIGH RV RESULTS OF 11891.6, 11829.5, 11325.7, 11401.4 AND 11416.4 PG/ML VERSUS THE EXPECTED RESULT OF 28500 PG/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 VITROS NBNP2 RESULTS WERE OBTAINED WHEN THE CUSTOMER WAS PROCESSING A NON-PATIENT FLUID. THERE HAS BEEN 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)(6) AND REPORTABILITY ASSESSMENT (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19462128 ↗
• MalfunctionFeb 22, 2024High Test Results; Low Test Results; Non Reproducible Results; High Test Results; Low Test Results; Non Reproducible Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT NON-REPRODUCIBLE, HIGHER THAN EXPECTED VITROS TROPI ES RESULTS WERE OBTAINED FROM SAMPLES FROM FOUR DIFFERENT PATIENTS WHEN PROCESSED ON A VITROS 5600 INTEGRATED SYSTEM (SYSTEM 1). VITROS TROPONIN I ES, LOT 5370 ON SYSTEM 1 PATIENT 1, SAMPLE 1 RESULT OF 0.072 NG/ML VERSUS THE EXPECTED RESULT OF <0.012 NG/ML PATIENT 1, SAMPLE 2 RESULT OF 0.083 NG/ML VERSUS THE EXPECTED RESULT OF <0.012 NG/ML PATIENT 2, SAMPLE 1 RESULT OF 0.044 NG/ML VERSUS THE EXPECTED RESULT OF <0.012 NG/ML PATIENT 2, SAMPLE 2 RESULT OF 0.049 NG/ML VERSUS THE EXPECTED RESULT OF <0.012 NG/ML PATIENT 3, SAMPLE 1 RESULT OF 0.039 NG/ML VERSUS THE EXPECTED RESULT OF <0.012 NG/ML PATIENT 4, SAMPLE 1 RESULT OF 0.062 NG/ML VERSUS THE EXPECTED RESULT OF <0.012 NG/ML PATIENT 4, SAMPLE 2 RESULT OF 0.039 NG/ML VERSUS THE EXPECTED RESULT OF <0.012 NG/ML IN ADDITION, THE INVESTIGATION DETERMINED THAT LOWER THAN EXPECTED VITROS TSH AND VITROS NBNP2 RESULTS WERE OBTAINED WHEN PROCESSING ORTHO FREE THYROID CONTROL AND NON-ORTHO QUALITY CONTROL FLUIDS ON A VITROS 5600 INTEGRATED SYSTEM (SYSTEM 1). VITROS TSH, LOT 7180 ON SYSTEM 1 BI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18762916 ↗
• MalfunctionSep 13, 2023Low Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A LOWER THAN EXPECTED VITROS NBNP2 RESULT WAS OBTAINED WHEN A SPANISH PREANALYTICAL QUALITY MONITORING PROGRAM (SEQC) PROFICIENCY SAMPLE WAS TESTED USING VITROS NBNP2 LOT 0610 ON A VITROS XT7600 INTEGRATED SYSTEM. SEQC JULY 2023 SAMPLE RESULT OF 164.06 PG/ML VERSUS THE MEAN RESULT OF 322 PG/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 VITROS NBNP2 RESULT WAS OBTAINED AS WHEN THE CUSTOMER WAS PROCESSING A NON-PATIENT SAMPLE. ORTHO HAS NOT BEEN MADE AWARE OF ANY 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 17735742 ↗
• MalfunctionJun 28, 2023High Test Results; High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED VITROS NT PRO-BNP II RESULTS WERE OBTAINED FROM NON-VITROS BIORAD QC FLUIDS AND NUMEROUS PATIENT SAMPLES USING VITROS IMMUNODIAGNOSTICS PRODUCTS NT PRO-BNP II REAGENT LOTS 0091, 0125 AND 0130 IN COMBINATION WITH A VITROS 5600 INTEGRATED SYSTEM. VITROS NBNP2 LOT 0091 RESULTS: BIORAD LEVEL 1 QUALITY CONTROL RESULTS OF 1574, 1573, 1574, 1576, 1572, 1576 AND 1575 PG/ML VS. EXPECTED RESULT OF 50.6 PG/ML. BIORAD LEVEL 3 QUALITY CONTROL RESULTS OF 4161, 4067, 4145, 4104 AND 4096 PG/ML VS. EXPECTED RESULT OF 2830 PG/ML. PATIENT 2 RESULT OF 1560 PG/ML VS. EXPECTED RESULT OF 38 PG/ML. PATIENT 3 RESULT OF 1770 PG/ML VS. EXPECTED RESULT OF 253 PG/ML. PATIENT 5 RESULT OF 1630 PG/ML VS. EXPECTED RESULT OF 106 PG/ML. PATIENT 7 RESULT OF 2260 PG/ML VS. EXPECTED RESULT OF 710 PG/ML. PATIENT 8 RESULT OF 1560 PG/ML VS. EXPECTED RESULT OF 39 PG/ML. VITROS NBNP2 LOT 0125 RESULTS: BIORAD LEVEL 1 QUALITY CONTROL RESULTS OF 1573 PG/ML VS. EXPECTED RESULT OF 50.6 PG/ML. BIORAD LEVEL 3 QUALITY CONTROL RESULTS OF 4073 PG/ML VS. EXPECTED RESULT OF 2830 PG/ML. VITROS NBNP2 LOT 0130 RESULTS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17219456 ↗
• MalfunctionJun 28, 2023High Test Results; High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED VITROS NT PRO-BNP II RESULTS WERE OBTAINED FROM NON-VITROS BIORAD QC FLUIDS AND NUMEROUS PATIENT SAMPLES USING VITROS IMMUNODIAGNOSTICS PRODUCTS NT PRO-BNP II REAGENT LOTS 0091, 0125 AND 0130 IN COMBINATION WITH A VITROS 5600 INTEGRATED SYSTEM. VITROS NBNP2 LOT 0091 RESULTS: BIORAD LEVEL 1 QUALITY CONTROL RESULTS OF 1574, 1573, 1574, 1576, 1572, 1576 AND 1575 PG/ML VS. EXPECTED RESULT OF 50.6 PG/ML. BIORAD LEVEL 3 QUALITY CONTROL RESULTS OF 4161, 4067, 4145, 4104 AND 4096 PG/ML VS. EXPECTED RESULT OF 2830 PG/ML. PATIENT 2 RESULT OF 1560 PG/ML VS. EXPECTED RESULT OF 38 PG/ML. PATIENT 3 RESULT OF 1770 PG/ML VS. EXPECTED RESULT OF 253 PG/ML. PATIENT 5 RESULT OF 1630 PG/ML VS. EXPECTED RESULT OF 106 PG/ML. PATIENT 7 RESULT OF 2260 PG/ML VS. EXPECTED RESULT OF 710 PG/ML. PATIENT 8 RESULT OF 1560 PG/ML VS. EXPECTED RESULT OF 39 PG/ML. VITROS NBNP2 LOT 0125 RESULTS: BIORAD LEVEL 1 QUALITY CONTROL RESULTS OF 1573 PG/ML VS. EXPECTED RESULT OF 50.6 PG/ML. BIORAD LEVEL 3 QUALITY CONTROL RESULTS OF 4073 PG/ML VS. EXPECTED RESULT OF 2830 PG/ML. VITROS NBNP2 LOT 0130 RESULTS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17219280 ↗
• MalfunctionJun 28, 2023High Test Results; High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED VITROS NT PRO-BNP II RESULTS WERE OBTAINED FROM NON-VITROS BIORAD QC FLUIDS AND NUMEROUS PATIENT SAMPLES USING VITROS IMMUNODIAGNOSTICS PRODUCTS NT PRO-BNP II REAGENT LOTS 0091, 0125 AND 0130 IN COMBINATION WITH A VITROS 5600 INTEGRATED SYSTEM. VITROS NBNP2 LOT 0091 RESULTS: BIORAD LEVEL 1 QUALITY CONTROL RESULTS OF 1574, 1573, 1574, 1576, 1572, 1576 AND 1575 PG/ML VS. EXPECTED RESULT OF 50.6 PG/ML. BIORAD LEVEL 3 QUALITY CONTROL RESULTS OF 4161, 4067, 4145, 4104 AND 4096 PG/ML VS. EXPECTED RESULT OF 2830 PG/ML. PATIENT 2 RESULT OF 1560 PG/ML VS. EXPECTED RESULT OF 38 PG/ML. PATIENT 3 RESULT OF 1770 PG/ML VS. EXPECTED RESULT OF 253 PG/ML. PATIENT 5 RESULT OF 1630 PG/ML VS. EXPECTED RESULT OF 106 PG/ML. PATIENT 7 RESULT OF 2260 PG/ML VS. EXPECTED RESULT OF 710 PG/ML. PATIENT 8 RESULT OF 1560 PG/ML VS. EXPECTED RESULT OF 39 PG/ML. VITROS NBNP2 LOT 0125 RESULTS: BIORAD LEVEL 1 QUALITY CONTROL RESULTS OF 1573 PG/ML VS. EXPECTED RESULT OF 50.6 PG/ML. BIORAD LEVEL 3 QUALITY CONTROL RESULTS OF 4073 PG/ML VS. EXPECTED RESULT OF 2830 PG/ML. VITROS NBNP2 LOT 0130 RESULTS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17219237 ↗
• MalfunctionMar 8, 2023High Test Results; High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT DISCORDANT, HIGHER THAN EXPECTED NTBNP RESULTS WERE OBTAINED FROM A SINGLE PATIENT SAMPLE WHEN TESTED USING VITROS NBNP2 LOT: 0072 ON TWO VITROS 3600 IMMUNODIAGNOSTIC SYSTEMS. THE RESULTS WERE DISCORDANT WHEN COMPARED TO VITROS NT-PROBNP RESULTS FOR THE SAME PATIENT SAMPLE. PATIENT 1, VITROS NBNP2 RESULTS OF 691.79, 650.96 AND 607.54 PG/ML VERSUS A VITROS NT-PROBNP RESULT OF 63.5 PG/ML BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE DISCORDANT, HIGHER THAN EXPECTED VITROS NBNP2 RESULTS WERE OBTAINED WHEN THE CUSTOMER WAS PROCESSING A PATIENT SAMPLE AS PART OF VALIDATION OF THE VITROS NBNP2 REAGENT METHOD AT THE CUSTOMER SITE. ORTHO HAS NOT BEEN MADE AWARE OF ANY ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16504173 ↗
• MalfunctionMar 7, 2023Low Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT DISCORDANT, LOWER THAN EXPECTED NT-PROBNP (NBNP2) RESULTS WERE OBTAINED WHEN A CUSTOMER PROCESSED MULTIPLE PATIENT SAMPLES USING VITROS NBNP2 LOT 0050 ON A VITROS XT7600 INTEGRATED SYSTEM. THE RESULTS WERE DISCORDANT WHEN COMPARED TO VITROS NT-PROBNP LOT 3170 RESULTS FOR THE SAME PATIENT SAMPLES TESTED AT THE SAME TIME ON THE SAME VITROS XT7600 INTEGRATED SYSTEM. PATIENT 1, VITROS NBNP2 RESULT OF 173.23 PG/ML VERSUS THE VITROS NT-PROBNP RESULT OF 240.85 PG/ML PATIENT 2, VITROS NBNP2 RESULT OF 172.94 PG/ML VERSUS THE VITROS NT-PROBNP RESULT OF 242.39 PG/ML PATIENT 3, VITROS NBNP2 RESULT OF 3009.34 PG/ML VERSUS THE VITROS NT-PROBNP RESULT OF 4039.31 PG/ML PATIENT 4, VITROS NBNP2 RESULT OF 176.29 PG/ML VERSUS THE VITROS NT-PROBNP RESULT OF 258.69 PG/ML PATIENT 5, VITROS NBNP2 RESULT OF 175.09 PG/ML VERSUS THE VITROS NT-PROBNP RESULT OF 250.84 PG/ML BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE DISCORDANT, LOWER THAN EXPECTED VITROS NBNP2 RESULTS WERE OBTAINED WHEN THE CUSTOMER WAS PERFORMING A PA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16493969 ↗
• MalfunctionJan 11, 2023High Test Results; High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A HIGHER THAN EXPECTED VITROS NT PRO-BNP II RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE WHEN USING VITROS IMMUNODIAGNOSTICS PRODUCTS NT PRO-BNP II REAGENT LOT 0440 IN COMBINATION WITH A VITROS 5600 INTEGRATED SYSTEM. PATIENT SAMPLE RESULT OF >30000 PG/ML VERSUS THE EXPECTED RESULT OF <300 PG/ML BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE DISCORDANT VITROS RESULT WAS NOT REPORTED FROM THE LABORATORY. ORTHO HAS NOT BEEN MADE AWARE OF ANY 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 600489.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16138781 ↗