VITROS 6802153Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10758750002054), received between Feb 6, 2023 and Mar 10, 2026 — classified as 18 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (9 reports).

1 FDA recall record name this device's identifier.

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 8, 2019Terminated

   Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System

   Z-2177-2019 · Root cause: Software design · FDA record ↗

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.

• MalfunctionMar 10, 2026Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A LOWER-THAN-EXPECTED VITROS AMMONIA (AMON) RESULT OBTAINED FROM A VITROS LIQUID PERFORMANCE VERIFIER (LPV) PROCESSED USING VITROS CHEMISTRY PRODUCTS AMON SLIDES LOT 1020-0267-3614 ON A VITROS 350 CHEMISTRY SYSTEM. VITROS LPV II LOT M2779 RESULT OF 134.0 UMOL/L VERSUS AN EXPECTED RESULT OF 191.8 UMOL/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 AMON RESULT WAS OBTAINED WHEN PROCESSING A CONTROL FLUID AND NO RESULTS WERE REPORTED OUT OF THE LABORATORY. THE CUSTOMER STATED THAT NO PATIENT SAMPLE RESULTS HAD BEEN QUESTIONED. HOWEVER, THE INVESTIGATION CANNOT CONCLUDE THAT PATIENT SAMPLE RESULTS WERE NOT OR WOULD NOT BE AFFECTED IF THE EVENT WERE TO RECUR UNDETECTED. THERE HAVE BEEN NO 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 24560274 ↗
• MalfunctionFeb 5, 2026High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A HIGHER THAN EXPECTED VITROS SODIUM (NA+) RESULT WAS OBTAINED FROM A SINGLE LEVEL OF A NON-VITROS THERMOFISHER MAS CONTROL (LOT OCR2608) USING VITROS NA+ SLIDE LOT 4203-1176-6973 ON A VITROS 350 CHEMISTRY SYSTEM. MAS OCR2608 LEVEL 1 RESULT OF 140.5 MMOL/L VS. THE EXPECTED RESULT OF 120.5 MMOL/L THE HIGHER THAN EXPECTED RESULTS WERE OBTAINED FROM A NON-PATIENT QUALITY CONTROL SAMPLE, HOWEVER, THE INVESTIGATION CANNOT CONCLUDE THAT PATIENT SAMPLE RESULTS WERE NOT OR WOULD NOT BE AFFECTED IF THE EVENT WERE TO RECUR UNDETECTED. THERE WERE 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 613239.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24271063 ↗
• MalfunctionJun 25, 2025Low Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A LOWER THAN EXPECTED VITROS AMON RESULT WAS OBTAINED FROM A VITROS LIQUID PERFORMANCE VERIFIER (LPV) PROCESSED USING VITROS CHEMISTRY PRODUCTS AMMONIA (AMON) SLIDES LOT 1020-0267-8941 ON A VITROS 350 CHEMISTRY SYSTEM. LPV II LOT K2576 VITROS AMON RESULTS OF 128, 132, 137, 139, 142, 133.2, 132.5, AND 119.6 UMOL/L VERSUS THE EXPECTED RESULT OF 182.0 UMOL/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 AMON RESULTS WERE OBTAINED WHEN PROCESSING A CONTROL FLUID. NO RESULTS WERE REPORTED OUT OF THE LABORATORY. THE CUSTOMER CLAIMED THAT PATIENT RESULTS WERE NOT IMPACTED BY THIS ISSUE, HOWEVER, THE INVESTIGATION CANNOT CONCLUDE THAT PATIENT SAMPLE RESULTS WOULD NOT BE AFFECTED IF THE EVENT WERE TO RECUR UNDETECTED. 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 22327386 ↗
• MalfunctionJan 21, 2025Low Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED VITROS CKMB RESULTS WERE OBTAINED FROM VITROS ISOENZYME PERFORMANCE VERIFIER (PV) QUALITY CONTROL (QC) FLUIDS PROCESSED ON A VITROS 350 CHEMISTRY SYSTEM. VITROS ISOENZYME PVI LOT U1670 RESULTS OF 12.0, 12.6, 14.4, 12.3 VERSUS THE EXPECTED RESULT OF 20.8 U/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 CUSTOMER INDICATED THAT PATIENT RESULTS WERE NOT AFFECTED BECAUSE THE QC RESULTS WERE UNACCEPTABLE. THERE WERE NO 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 21196530 ↗
• MalfunctionSep 3, 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 AMMONIA (AMON) RESULT WAS OBTAINED FROM A VITROS LIQUID PERFORMANCE VERIFIER (LPV) PROCESSED USING VITROS CHEMISTRY PRODUCTS AMON SLIDES LOT 1020-0265-3649 ON A VITROS 350 CHEMISTRY SYSTEM. VITROS LPV I LOT D1516 RESULT OF 112.3 UMOL/L VERSUS AN EXPECTED RESULT OF 42.6 UMOL/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 AMON RESULT WAS OBTAINED WHEN PROCESSING A CONTROL FLUID DURING PRECISION TESTING. NO RESULTS WERE REPORTED OUT 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 20128832 ↗
• MalfunctionJul 9, 2024Low Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED POTASSIUM (K+) RESULTS WERE OBTAINED FROM A VITROS PERFORMANCE VERIFIER (PV) USING VITROS CHEMISTRY PRODUCTS K+ SLIDES LOT 4102-1138-1818 ON A VITROS 350 CHEMISTRY SYSTEM. VITROS PV II LOT N9816 RESULTS OF 3.02 AND 3.27 MMOL/L VS THE EXPECTED RESULT OF 5.59 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 FROM A QUALITY CONTROL FLUID AND WERE NOT REPORTED FROM THE LABORATORY. HOWEVER, THE INVESTIGATION CANNOT CONCLUDE THAT PATIENT SAMPLE RESULTS WERE NOT OR WOULD NOT BE AFFECTED IF THE EVENT WERE TO RECUR UNDETECTED. 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 19705548 ↗
• MalfunctionJun 20, 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 SODIUM (NA+) RESULT WAS OBTAINED FROM A SINGLE LEVEL OF NON-VITROS BIORAD LOT 56740 CONTROL USING VITROS NA+ SLIDE LOT 4234-1120-5575 ON A VITROS 350 CHEMISTRY SYSTEM. BIORAD MULTIQUAL LOT 56740 LEVEL 3 RESULT OF 141.0 MMOL/L VERSUS THE EXPECTED RESULT OF 162.2 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 NA+ RESULT WAS OBTAINED FROM A NON-PATIENT QUALITY CONTROL FLUID. 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 19575361 ↗
• MalfunctionMar 4, 2024Low Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED SODIUM (NA+) RESULTS WERE OBTAINED FROM A NON-VITROS BIORAD QUALITY CONTROL FLUID USING VITROS CHEMISTRY PRODUCTS NA+ SLIDES LOT 4218-1101-9669 ON A VITROS 350 CHEMISTRY SYSTEM. VITROS NA+ BIORAD LOT 92960 LEVEL 2 RESULTS OF 141, 141, 144, AND 143 MMOL/L VERSUS THE EXPECTED RESULT OF 156 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 NA+ RESULTS WERE OBTAINED FROM A QUALITY CONTROL FLUID AND NO RESULTS WERE 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 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18828325 ↗
• MalfunctionFeb 29, 2024Data Problem; Data Problem

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT THAT THE SAMPLE ID FOR A PATIENT SAMPLE WAS ASSOCIATED WITH THE INCORRECT PATIENT NAME AND TESTS WHEN PROCESSED ON A VITROS 350 CHEMISTRY SYSTEM. MIS-ASSOCIATED PATIENT RESULTS MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THE MIS-ASSOCIATED RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO REPORT 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 18807006 ↗
• MalfunctionJan 12, 2024High 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 VITROS LIQUID PERFORMANCE VERIFIERS (LPV) AND NON-VITROS BIORAD QUALITY CONTROL FLUIDS PROCESSED USING VITROS CHEMISTRY PRODUCTS AMON SLIDES LOT 1020-0262-4671 ON A VITROS 350 CHEMISTRY SYSTEM. VITROS LPV I LOT D1516 RESULTS OF 115.0, 213.0 AND 118.0 UMOL/L VERSUS AN EXPECTED RESULT OF 42.6 UMOL/L VITROS LPV II LOT E1517 RESULTS OF 308.0 AND 255.0 UMOL/L VERSUS AN EXPECTED RESULT OF 191.9 UMOL/L BIORAD LOT 54410 LEVEL 1 RESULTS OF 217.8, 112.2 AND 103.0 UMOL/L VERSUS AN EXPECTED RESULT OF 31.24 UMOL/L BIORAD LOT 54410 LEVEL 2 RESULTS OF 171.9, 117.8 AND 189.9 UMOL/L VERSUS AN EXPECTED RESULT OF 93.03 UMOL/L BIORAD LOT 54410 LEVEL 3 RESULTS OF 362.4, 398.7, 307.3, 283.7, 384.6 AND 292.8 UMOL/L VERSUS AN EXPECTED RESULT OF 233.63 UMOL/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 AMON RESULTS WERE OBTAINED WHEN PROCESSING CONTROL FLUIDS. NO RESULTS WERE REPORTED OUT OF THE LABOR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18503469 ↗
• MalfunctionJan 3, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A SAMPLE ID FOR A PATIENT SAMPLE WAS ASSOCIATED WITH THE INCORRECT PATIENT NAME AND TEST WHEN PROCESSED ON A VITROS 350 CHEMISTRY SYSTEM. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE CUSTOMER IDENTIFIED THE DISCREPANCY, AND NO ERRONEOUS RESULTS WERE REPORTED OUT 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 604492.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18438888 ↗
• MalfunctionSep 19, 2023High Test Results; High Test Results

  THE CUSTOMER REPORTED A HIGHER THAN EXPECTED VITROS AMON RESULT OBTAINED FROM A SINGLE LEVEL OF NON-VITROS BIORAD ETHANOL/AMMONIA CONTROLS, LOT 54380, TESTED ON A VITROS 350 CHEMISTRY SYSTEM. BIORAD L3 AMON = 259.0 UMOL/L VS. THE BASELINE MEAN 213.14 UMOL/L. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THE RESULTS WERE TO RECUR UNDETECTED. THE HIGHER THAN EXPECTED VITROS AMON RESULTS WERE GENERATED FROM NON-PATIENT FLUIDS, HOWEVER THE INVESTIGATION CANNOT CONCLUDE THAT PATIENT SAMPLE RESULTS WERE NOT AFFECTED AND 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. COMPLAINT NUMBER (B)(4) / REPORTABILITY ASSESSMENT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17772388 ↗
• MalfunctionSep 7, 2023Low Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED POTASSIUM RESULTS WERE OBTAINED FROM A NON-VITROS MAS QUALITY CONTROL FLUID USING VITROS CHEMISTRY PRODUCTS POTASSIUM (K+) SLIDES LOT 4102-1106-2795 AND LOT 4102-1099-0284 ON A VITROS 350 CHEMISTRY SYSTEM . VITROS K+ LOT 4102-1106-2795 VITROS K+ MAS LEVEL 3 RESULTS OF 4.14 AND 4.39 MMOL/L VS THE EXPECTED RESULT OF 6.22 MMOL/L VITROS K+ LOT 4102-1099-0284 VITROS K+ MAS LEVEL 3 RESULTS OF 4.11 MMOL/L VS THE EXPECTED RESULT OF 6.22 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 FROM A NON-PATIENT FLUID. 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 17699170 ↗
• MalfunctionJun 30, 2023Low Test Results; Low Test Results

  HOLD NW.A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED VITROS SODIUM (NA+) AND POTASSIUM (K+) RESULTS WERE OBTAINED A NON-VITROS BIORAD QUALITY CONTROL FLUID WHEN USING VITROS NA+ LOT 4205-1089-3956 AND VITROS K+ LOT 4102-1092-5812 PROCESSED ON A VITROS 350 CHEMISTRY SYSTEM. NA+ BIORAD LOT 92920 LEVEL 2 RESULTS OF 130.0, 115.0, 100.0, 141.0, 103.3, 132.2, 73.6, AND 87.1 MMOL/L VERSUS THE EXPECTED BASELINE RESULT OF 154.0 MMOL/L K+ BIORAD LOT 92920 LEVEL 2 RESULT 4.18 MMOL/L VERSUS THE EXPECTED BASELINE RESULT OF 6.30 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 NON-PATIENT QC FLUIDS. NO UNEXPECTED VITROS NA+ OR VITROS K+ PATIENT RESULTS REPORTED FROM THE LABORATORY. THERE WERE NO ALLEGATIONS 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 17240996 ↗
• MalfunctionJun 7, 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 POTASSIUM (K+) RESULT WAS OBTAINED FROM A SINGLE LEVEL OF VITROS PERFORMANCE VERIFIER (PV) I, LOT M9814, TESTED ON A VITROS 350 CHEMISTRY SYSTEM. VITROS PV I LOT M9814 RESULT OF 4.1 MMOL/L, VS. THE EXPECTED RESULT OF 2.92 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 VITROS PV I FLUID WAS A NON-PATIENT SAMPLE, AND THE RESULT WAS 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 17083386 ↗
• MalfunctionApr 11, 2023High 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 HIGHER THAN EXPECTED RESULTS FROM A SINGLE LEVEL OF VITROS LIQUID PERFORMANCE VERIFIER (LCV) I, LOT B9937, USING VITROS AMMONIA (AMON) SLIDE LOT 1020-0262-5362 TESTED ON A VITROS 350 CHEMISTRY SYSTEM. VITROS LPV I B9937 RESULTS OF 108.8, 117.1, 128.6, 105.4, 102.6, 101.7, 124.7, 140.7, 138.1, 117.1, 93.7, 117.1, 94.8, 99.9 AND 117.2 UMOL/L COMPARED TO AN EXPECTED RESULT OF 45.6 UMOL/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 AMON RESULTS WERE OBTAINED FROM A NON-PATIENT VITROS LPV QUALITY CONTROL FLUID. 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 16715570 ↗
• MalfunctionApr 10, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT THE SIDS FOR MULTIPLE PATIENT SAMPLES WERE ASSOCIATED WITH THE INCORRECT PATIENT NAMES AND ASSAYS WHEN PROCESSED ON A VITROS 350 CHEMISTRY SYSTEM. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE CUSTOMER IDENTIFIED THE DISCREPANCY AND NO ERRONEOUS RESULTS WERE REPORTED. 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 16709493 ↗
• MalfunctionFeb 6, 2023Low Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED VITROS AMMONIA (AMON) RESULTS WERE OBTAINED FROM A VITROS LIQUID PERFORMANCE VERIFIER PROCESSED USING VITROS CHEMISTRY PRODUCTS AMON SLIDES LOT: 1018-0257-6733 ON A VITROS 350 CHEMISTRY SYSTEM. VITROS LPV II LOT: X9323 RESULTS OF 136.0, 147.0 AND 143.0 UMOL/L VERSUS AN EXPECTED RESULT OF 186.2 UMOL/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 AMON RESULTS WERE OBTAINED WHEN PROCESSING A CONTROL FLUID DURING PRECISION TESTING. NO RESULTS WERE REPORTED OUT OF THE LABORATORY. ORTHO WAS NOT 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 16302871 ↗