VITROS 6802445Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10758750012343), received between Jan 4, 2023 and Jun 23, 2026 — classified as 18 malfunctions.

The most frequently reported specific device problem is “High Test Results” (11 reports).

9 FDA recall records name this device's identifier, 6 still open.

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. May 9, 2025Open, Classified

   a software anomaly allows test results to be reported using Micro Tip and Micro Slide diluent packs that the system treats as expired even when the Use Expired Reagents setting is not enabled if a shelf expiration date is omitted during manual loading. The issue was identified by a customer complaint, in which a CREA Urine test was processed with an RE (Reagent Expired) code, even though the diluent pack was not expired and the use-expired-reagents setting was disabled. This can result in erroneous test results and/or delaying test results.

   Z-2039-2025 · Root cause: Software design · FDA record ↗

2. May 9, 2025Open, Classified

   a software anomaly allows test results to be reported using Micro Tip and Micro Slide diluent packs that the system treats as expired even when the Use Expired Reagents setting is not enabled if a shelf expiration date is omitted during manual loading. The issue was identified by a customer complaint, in which a CREA Urine test was processed with an RE (Reagent Expired) code, even though the diluent pack was not expired and the use-expired-reagents setting was disabled. This can result in erroneous test results and/or delaying test results.

   Z-2040-2025 · Root cause: Software design · FDA record ↗

3. Dec 19, 2024Open, Classified

   The VITROS XT 7600 Integrated System software versions 3.8.0 may not correctly notify users if the Signal Reagent Pack exceeds the on-board and/or shelf-life expiration date. This could result in the use of expired products, which would increase the risk of no results or erroneous results from the instrument.

   Z-1006-2025 · Root cause: Software Design Change · FDA record ↗

4. Jan 26, 2024Open, Classified

   A software defect affecting VITROS Systems running VITROS Software Versions 3.8.1 causes QC baseline statistics to not update as expected when changed by the user. This may cause erroneous patient results to be reported.

   Z-1225-2024 · Root cause: Software Design Change · FDA record ↗

5. Jan 26, 2024Open, Classified

   A software defect affecting VITROS Systems running VITROS Software Versions 3.8.0 and 3.8.1 causes the Configurable Westgard Rules to not report as expected. When a new control is defined, configurable Westgard rules, if selected, are not flagged or reported with the applicable QC results if the statistical criteria is met. This may result in acceptance of QC results that do not meet acceptance criteria, which may cause erroneous patient results to be reported.

   Z-1230-2024 · Root cause: Software Design Change · FDA record ↗

6. Oct 10, 2023Open, Classified

   During planned monitoring of data post-release of Software Version 3.8.0 an increased occurrence of software issues relating to unresponsive subsystems, unresponsive user interface (sometimes referred to as a screen freeze), and/or printer disconnections was identified. The consequence of these issues would be a delay in reporting results due to the required system shutdowns to recover the system. This delay in reporting results could occur during any assay, including which the speed of the result is deemed critical or STAT and could result in a delay of treatment in a patient. Due to the release strategy of this software version, the user could not update the system but a field engineer had to manually install each affected system.

   Z-0544-2024 · Root cause: Under Investigation by firm · FDA record ↗

7. Jul 8, 2019Terminated

   Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System

   Z-2181-2019 · Root cause: Software design · FDA record ↗

8. Oct 19, 2018Terminated

   Software anomaly may incorrectly extend the on-analyzer stability time for a loaded VITROS Reagent.

   Z-0653-2019 · Root cause: Software Manufacturing/Software Deployment · FDA record ↗

9. Apr 6, 2015Terminated

   Software anomaly allows testing of multiple assays using a single urine specimen, regardless of the pretreatment requirements for each selected assay, potentially leading to biased patient results.

   Z-1742-2015 · 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.

• MalfunctionJun 23, 2026Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED AMMONIA (AMON) RESULTS WERE OBTAINED FROM A VITROS LIQUID PERFORMANCE VERIFIER II (LPVII) FLUID PROCESSED USING VITROS CHEMISTRY PRODUCTS AMON SLIDES ON A VITROS 4600 CHEMISTRY SYSTEM. VITROS LPVII LOT P3086 LEVEL 2 RESULTS OF 157.65, 147.38, 155.91, 157.98, 123.94, 152.41, 158.82, 149.51, 145.62, 146.78 UMOL/L VS THE EXPECTED RESULT OF 198.7 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. 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 614959.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25600020 ↗
• MalfunctionJun 8, 2026Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A LOWER THAN EXPECTED RESULT OBTAINED FROM A SINGLE LEVEL OF NON-VITROS MAS ALCOHOL/AMMONIA CONTROL, LOT A/A2709, USING VITROS CHEMISTRY PRODUCTS AMON SLIDE LOT 1023-0271- 0638 ON A VITROS 4600 CHEMISTRY SYSTEM. MAS L2 VITROS AMON RESULT OF 127.3 UMOL/L VS. THE EXPECTED RESULT OF 160.4 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 FROM A NON-PATIENT QUALITY CONTROL FLUID AND THERE WAS NO ALLEGATION OF PATIENT HARM. 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 25436355 ↗
• MalfunctionApr 7, 2026High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED RESULTS WERE OBTAINED FROM A NON-VITROS BIORAD QUALITY CONTROL USING VITROS CHEMISTRY PRODUCTS POTASSIUM (K+) SLIDES LOT: 4102-1201-0548 PROCESSED ON A VITROS 4600 CHEMISTRY SYSTEM. BIORAD LOT: 46030 LEVEL 1 RESULTS OF 3.75, 3.78, 3.79, 3.85, 3.77 AND 3.79 MMOL/L VS AN EXPECTED RESULT OF 2.57 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 RESULTS WERE OBTAINED FROM QUALITY CONTROL FLUIDS AND NO RESULTS WERE REPORTED FROM THE LABORATORY. PATIENT SAMPLES WERE AFFECTED, HOWEVER, NONE OF THE PATIENT SAMPLE RESULTS BREACHED POTENTIAL HEALTH AND SAFETY CRITERIA AND THE RESULTS WERE NOT REPORTED FROM THE LABORATORY. 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).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24809295 ↗
• MalfunctionApr 3, 2026High Test Results; Non Reproducible Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED, NON-REPRODUCIBLE VITROS NA+ RESULTS OBTAINED FROM A SINGLE NON-VITROS BIORAD MULTIQUAL UNASSAYED CONTROL, LOT 56760 FLUID AND A SINGLE VITROS PERFORMANCE VERIFIER (PV) I, LOT: E2828 FLUID USING VITROS CHEMISTRY PRODUCTS SODIUM (NA+) SLIDE LOT: 4206-1179- 8305 ON A VITROS 4600 CHEMISTRY SYSTEM. BIORAD L1 VITROS NA+ RESULT OF >250 MMOL/L VS. THE EXPECTED BASELINE MEAN RESULT OF 109.8 MMOL/L VITROS PV I LOT: E2828 VITROS NA+ RESULT OF >250 MMOL/L VS. THE EXPECTED RANGE OF MEANS MIDPOINT VALUE OF 125.8 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 NA+ RESULTS WERE OBTAINED FROM NON-PATIENT QUALITY CONTROL FLUID, HOWEVER, PATIENT SAMPLE RESULTS WERE ALSO AFFECTED BUT THE RESULTS 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).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24778105 ↗
• MalfunctionMar 11, 2026High Test Results

  THE INVESTIGATION CONCLUDED THAT HIGHER THAN EXPECTED RESULTS WERE OBTAINED FROM TWO DIFFERENT LEVELS OF NON-VITROS BIORAD ETHANOL/AMMONIA CONTROLS, LOT: 54470, USING VITROS AMMONIA (AMON) SLIDE LOT: 1023-0271-0768 ON A VITROS 4600 CHEMISTRY SYSTEM. BIORAD LEVEL 1 VITROS AMON RESULTS OF 146.5 AND 320.3 UMOL/L VS. THE EXPECTED RESULT OF 27.5 UMOL/L BIORAD LEVEL 3 RESULTS OF 288.1, 493.5, 283.7 AND 299.0 UMOL/L VS. THE EXPECTED RESULT OF 236.0 UMOL/L THE HIGHER-THAN-EXPECTED RESULTS WERE OBTAINED FROM NON-PATIENT QUALITY CONTROL FLUIDS. THERE WAS NO REPORT OF AFFECTED PATIENT RESULTS 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 24574460 ↗
• MalfunctionFeb 24, 2026Low 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 PROCESSING A SINGLE PATIENT SAMPLE USING VITROS NA+ SLIDE LOT 4201-1173-6380 ON A VITROS 4600 CHEMISTRY SYSTEM. THE RESULT WAS LOWER THAN EXPECTED WHEN COMPARED TO A VITROS RESULT OBTAINED FROM TESTING THE SAME PATIENT SAMPLE ON AN ALTERNATE VITROS ANALYZER ON SITE. PATIENT SAMPLE 1 VITROS RESULT OF 126.0 MMOL/L VS. THE EXPECTED RESULT OF 169.0 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 RESULT WAS OBTAINED FROM THE SINGLE PATIENT SAMPLE BUT WAS NOT RELEASED FROM THE LABORATORY. THE CUSTOMER CONFIRMED THAT 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 24433647 ↗
• MalfunctionDec 23, 2025High 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 THAT NON-REPRODUCIBLE, HIGHER THAN EXPECTED VITROS GLUCOSE (GLU) RESULTS WERE OBTAINED FROM EIGHT DIFFERENT PATIENT SAMPLES TESTED ON A VITROS 4600 CHEMISTRY SYSTEM. PATIENT SAMPLE 1: VITROS GLU RESULT OF 18.95 MMOL/L VS. THE REPEAT RESULT OF 5.8 MMOL/L PATIENT SAMPLE 2: VITROS GLU RESULT OF 19.06 MMOL/L VS. THE REPEAT RESULT OF 7.4 MMOL/L PATIENT SAMPLE 3: VITROS GLU RESULT OF 19.17 MMOL/L VS. THE REPEAT RESULT OF 7.8 MMOL/L PATIENT SAMPLE 4: VITROS GLU RESULT OF 19.07 MMOL/L VS. THE REPEAT RESULT OF 5.8 MMOL/L PATIENT SAMPLE 6: VITROS GLU RESULT OF 18.73 MMOL/L VS. THE REPEAT RESULT OF 6.1 MMOL/L PATIENT SAMPLE 7: VITROS GLU RESULT OF 19.03 MMOL/L VS. THE REPEAT RESULT OF 6.2 MMOL/L PATIENT SAMPLE 8: VITROS GLU RESULT OF 18.95 MMOL/L VS. THE REPEAT RESULT OF 5.8 MMOL/L PATIENT SAMPLE 9: VITROS GLU RESULT OF 18.92 MMOL/L VS. THE REPEAT RESULT OF 5.4 MMOL/L BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. ALL EIGHT OF THE HIGHER THAN EXPECTED VITROS GLU RESULTS WERE REPORTED FROM THE LABORATORY, HOWE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23876590 ↗
• MalfunctionNov 13, 2025High Test Results; High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A HIGHER-THAN-EXPECTED SODIUM (NA+) RESULT WAS OBTAINED DURING A WITHIN RUN PRECISION TEST FROM A VITROS PERFORMANCE VERIFIER (PV) USING VITROS CHEMISTRY PRODUCTS NA+ SLIDES LOT 4205-1178-7573 ON A VITROS 4600 CHEMISTRY SYSTEM. VITROS PV I LOT Y2110 RESULT OF 139.1 MMOL/L VS AN EXPECTED RESULT OF 120.8 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 NA+ RESULT WAS OBTAINED FROM A QUALITY CONTROL FLUID DURING WITHIN RUN PRECISION TESTING AND WAS NOT REPORTED FROM 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 23547533 ↗
• MalfunctionSep 9, 2025High Test Results; Low Test Results; High Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER AND LOWER THAN EXPECTED VITROS AMMONIA (AMON) RESULTS WERE OBTAINED FROM NON-VITROS BIORAD QUALITY CONTROL FLUIDS PROCESSED USING VITROS CHEMISTRY PRODUCTS AMON SLIDES LOT 1020-0267-8992 ON A VITROS 4600 CHEMISTRY SYSTEM. BIORAD LEVEL 2 LOT 54430 RESULTS OF 162.3, 162.8, 158.4, 63.2, 67.7, 67.9 UMOL/L VERSUS THE EXPECTED RESULT OF 92.0 UMOL/L BIORAD LEVEL 3 LOT 54430 RESULTS OF 168.7, 170.5 UMOL/L VERSUS THE EXPECTED RESULT OF 240.0 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 HIGHER AND LOWER THAN EXPECTED VITROS AMON RESULTS WERE OBTAINED WHEN PROCESSING CONTROL FLUIDS. NO RESULTS WERE 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 23003720 ↗
• MalfunctionApr 29, 2025Incorrect, 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 THAT DEMOGRAPHICS FOR A PATIENT (B) WERE MIS-ASSOCIATED WITH THE RESULTS OBTAINED FROM A SAMPLE TUBE FROM A DIFFERENT PATIENT (A) WHEN SAMPLES WERE PROCESSED ON A VITROS 4600 CHEMISTRY SYSTEM. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE CUSTOMER STATED THAT THE DISCREPANT PATIENT SAMPLE RESULTS WERE REPORTED OUT OF THE LABORATORY. HOWEVER, A PHYSICIAN QUESTIONED THE RESULTS AND REPEAT TESTING OCCURRED. NO TREATMENT WAS INITIATED, ALTERED OR STOPPED BASED ON THE RESULTS. THERE WAS NO ALLEGATION OF PATIENT HARM RELATED TO 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 21929418 ↗
• MalfunctionNov 25, 2024Low 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 NON-VITROS BIORAD QUALITY CONTROL FLUID PROCESSED USING VITROS CHEMISTRY PRODUCTS AMON SLIDES LOT 1019-0264-4175 ON A VITROS 4600 CHEMISTRY SYSTEM. BIORAD LOT 54410 LEVEL 2 RESULTS OF 73.1 AND 42.9 UMOL/L VS AN EXPECTED RESULT OF 91.6 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 LOWER-THAN-EXPECTED VITROS AMON RESULTS WERE OBTAINED WHEN PROCESSING A CONTROL FLUID. NO RESULTS WERE REPORTED OUT OF THE LABORATORY. THE CUSTOMER STATED THAT NO PATIENT RESULTS HAD BEEN AFFECTED OR QUESTIONED. 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 20771953 ↗
• MalfunctionOct 22, 2024High Test Results; Low Test Results; High Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER AND HIGHER THAN EXPECTED RESULTS WERE OBTAINED FROM TWO DIFFERENT LEVELS OF NON-VITROS BIORAD ETHANOL/AMMONIA CONTROLS, LOT 54390, USING VITROS AMMONIA (AMON) SLIDE LOTS 1019-0266-5803 AND SLIDE LOT 1020-0265-0764 ON A VITROS 4600 CHEMISTRY SYSTEM. VITROS AMON REAGENT SLIDE LOT 1020-0265-0764: BIORAD LEVEL 2 AMON RESULTS OF 61.71, 63.51, 112.45, 68.28, 70.84, 68.46, AND 62.67 ?MOL/L VS. THE EXPECTED RESULT OF 92.88 ?MOL/L BIORAD LEVEL 3 AMON RESULTS OF 187.76 ?MOL/L VS. THE EXPECTED RESULT OF 239.90 ?MOL/L VITROS AMON REAGENT SLIDE LOT 1019-0266-5803: BIORAD LEVEL 2 AMON RESULTS OF 122.83, 113.59, 72.81, AND 59.75 ?MOL/L VS. THE EXPECTED RESULT OF 92.40 ?MOL/L BIORAD LEVEL 3 AMON RESULTS OF 184.23 ?MOL/L VS. THE EXPECTED RESULT OF 242.10 ?MOL/L LIQUID PERFORMANCE VERIFIER II AMON RESULTS OF 129.17, 142.36, 143.74, 145.21, 145.97, 148.40, 149.81, 150.95, 152.00, 152.40, 153.53 AND 154.35 ?MOL/L VS. THE EXPECTED RESULT OF 194.70 ?MOL/L AFTER SERVICE INTERVENTIONS USING VITROS AMON REAGENT SLIDE LOT 1019-0266-5803: BIORAD LEVEL 2 AMON RESULTS OF 115.40, 115.04, AND 112.20 ?MOL/L

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20509233 ↗
• MalfunctionOct 14, 2024High 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 AND LOWER THAN EXPECTED VITROS AMMONIA (AMON) RESULTS WERE OBTAINED FROM NON-VITROS MAS QUALITY CONTROL FLUIDS AND A VITROS LIQUID PERFORMANCE VERIFIER (LPV) PROCESSED USING VITROS CHEMISTRY PRODUCTS AMON SLIDES LOT 1020-0265-7076 ON A VITROS 4600 CHEMISTRY SYSTEM. MAS ALCOHOL/AMMONIA CONTROL LOT 2409 LEVEL 1 VITROS AMON RESULT OF 292.2 UMOL/L VERSUS AN EXPECTED RESULT OF 25.0 UMOL/L MAS ALCOHOL/AMMONIA CONTROL LOT 2409 LEVEL 2 VITROS AMON RESULTS OF 117.7, 114.8, 102.3, 37.6, 111.2, 110.3, 76.8, 113.0, 102.0, 114.4, 92.4, 114.5, 115.1 AND 114.9 UMOL/L VERSUS AN EXPECTED RESULT OF 148.3 UMOL/L VITROS LPV II LOT T8395 RESULT OF 153.1 UMOL/L VS AN EXPECTED RESULT OF 203.4 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 AND LOWER THAN EXPECTED VITROS AMON RESULTS WERE OBTAINED WHEN PROCESSING CONTROL FLUIDS. THE CUSTOMER STATED THAT PATIENT RESULTS HAVE NOT BEEN AFFECTED AS SAMPLES WERE BEING PROCESSED FOR VITROS AMON ON AN ALTERNATE VITROS INSTRUMENT AT THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20441026 ↗
• MalfunctionJul 9, 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 SINGLE AMERICAN PROFICIENCY INSTITUTE (API) PROFICIENCY SURVEY SAMPLE USING VITROS AMON SLIDE LOT 1019-0264-4175 ON A VITROS 4600 CHEMISTRY SYSTEM. API PROFICIENCY SAMPLE RESULT OF 95.0 UMOL/L VS. THE EXPECTED API PEER TARGET RESULT OF 72.1 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 RESULT WAS OBTAINED FROM A API PROFICIENCY FLUID. THE CUSTOMER CONFIRMED THAT PATIENT RESULTS WERE NOT AFFECTED. 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 19703784 ↗
• MalfunctionDec 21, 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 NON-VITROS BIORAD LYPHOCHEK ASSAYED CHEMISTRY CONTROLS, LOT 89730, USING VITROS K+ SLIDE LOT 4102-1007-5442 ON A VITROS 4600 CHEMISTRY SYSTEM. BIORAD LEVEL 3 K+ RESULTS OF 4.99, 4.94, 4.74, 4.77, 476 AND 4.69 MMOL/L VS. THE EXPECTED RESULT OF 5.83 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 AFFECTED QUALITY CONTROL SAMPLES WERE NON-PATIENT SAMPLES. 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 604391.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18376181 ↗
• MalfunctionNov 17, 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 LOWER AND HIGHER THAN EXPECTED RESULTS WERE OBTAINED FROM TWO DIFFERENT LEVELS OF VITROS LIQUID PERFORMANCE VERIFIER (LPV) FLUIDS, USING VITROS AMMONIA (AMON) SLIDE LOT 1020-0260-1781 ON A VITROS 4600 CHEMISTRY SYSTEM. LPV I B9937 RESULTS OF 345.7 AND 339.5 UG/DL VS. THE EXPECTED RESULT OF 77.65 UG/DL. LPV II C9938 RESULT OF 198.6, 187.7, 239.5, 257.2, 200.2, 223.9, 273.6, 195.9, 247.8, 251.2, 213.3, 114.1, 238.7, 182.1, 267.5, AND 273.1 UMOL/L VS. THE EXPECTED RESULT OF 351.15 UG/DL. 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 REPORT OF AFFECTED PATIENT RESULTS AND THERE WAS NO ALLEGATION OF PATIENT HARM. 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 18162168 ↗
• MalfunctionApr 13, 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 AND LOWER THAN EXPECTED RESULTS WERE OBTAINED FROM A SINGLE LEVEL OF VITROS LIQUID PERFORMANCE VERIFIER (LPV) II FLUID, LOT X9323, AND A SINGLE LEVEL OF NON-VITROS BIORAD ETHANOL/AMMONIA CONTROL, LOT 54370, USING TWO DIFFERENT VITROS AMMONIA (AMON) SLIDE LOTS (1020-0262-4476 AND 1019-0263-9036) ON A VITROS 4600 CHEMISTRY SYSTEM. VITROS AMON SLIDE LOT 1020-0262-4476 BIORAD LEVEL 3 AMON RESULTS OF 186.5 AND 286.5 VS. THE EXPECTED RESULT OF 237.28.1 MOL/L. VITROS AMON SLIDE, LOT 1019-0263-9036, VITROS LPV II AMON RESULTS OF 144.8, 145.1, 158.4, 149.9, 158.0, 143.2, 130.7 AND 148.1 VS. THE EXPECTED RESULT OF 198.2 MOL/L BIORAD LEVEL 3 AMON RESULTS OF 185.0 AND 189.8 VS. THE EXPECTED RESULT OF 237.28.1 MOL/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 REPORT OF AFFECTED PATIENT RESULTS AND THERE WAS NO ALLEGATION OF PATIENT HARM. 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 16737177 ↗
• MalfunctionJan 4, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2022, A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT THAT THEIR VITROS 4600 CHEMISTRY SYSTEM WAS RUNNING A SAMPLE IN POSITION 1, IT WOULD THEN GO TO POSITION 5 FOR REFLEX DILUTION. IN THE OBSERVED CASE, NO TUBE WAS IN POSITION 5. 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 KNOWINGLY REPORTED FROM THE LABORATORY. THE CUSTOMER AND ORTHO HAVE NOT BEEN MADE AWARE OF ANY ALLEGATIONS 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 16097693 ↗