VITROS 1882208Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 10758750000166), received between Feb 8, 2023 and Jun 11, 2026 — classified as 23 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 13, 2026.

Most reported problems

Recent adverse event reports

The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 11, 2026High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED VITROS CALCIUM (CA+) AND VITROS GLU RESULTS OBTAINED FROM TWO LEVELS OF NON-VITROS BIORAD QUALITY CONTROL (QC) FLUID (LOT 46050) USING VITROS XT CHEMISTRY PRODUCTS GLU-CA MICROSLIDES, LOT 7427-0024-4218 ON A VITROS XT 3400 CHEMISTRY SYSTEM. THE RESULTS WERE HIGHER THAN EXPECTED WHEN COMPARED TO CUSTOMER BASELINE MEAN VALUES. VITROS XT CHEMISTRY PRODUCTS GLU-CA MICROSLIDES, LOT 7427-0024-4218: BIORAD LOT 46050 L1 VITROS CA RESULTS OF 8.94, 8.68, 8.83, AND 8.71 MG/DL VS THE BASELINE MEAN OF 5.85 MG/DL. BIORAD LOT 46050 L1 VITROS GLU RESULTS OF 535.6, 538.6, 530.8, 546.4, AND 530.6 MG/DL VS THE BASELINE MEAN OF 353.0 MG/DL. 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 CA+ AND GLU RESULTS WERE OBTAINED FROM A QUALITY CONTROL FLUID AND NO RESULTS WERE REPORTED FROM THE LABORATORY. THERE HAS BEEN NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMB

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25470427 ↗
• MalfunctionMay 29, 2026Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED VITROS LACTATE (LAC) RESULTS WERE OBTAINED FROM A SINGLE LEVEL OF NON-VITROS BIORAD MULTIQUAL UNASSAYED CONTROLS, LOT 45980, AND A SINGLE LEVEL OF VITROS PERFORMANCE VERIFIER (PV) FLUID USING VITROS LAC SLIDE LOT 3533-0131-6128 TESTED ON A VITROS XT7600 INTEGRATED SYSTEM. BIORAD LEVEL 2 VITROS LAC RESULTS OF 2.66, 2.53, 2.63, 2.71, 2.54, 2.52 AND 2.55 MMOL/L VS. THE BASELINE MEAN VALUE OF 3.22 MMOL/L VITROS PV II, LOT D2338 VITROS LAC RESULTS OF 2.71 AND 2.87 MMOL/L VS. THE RANGE OF MEANS MIDPOINT VALUE OF 3.76 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 LAC RESULTS WERE OBTAINED FROM NON-PATIENT QUALITY CONTROL FLUIDS. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THE EVENT. THIS REPORT IS NUMBER FOUR OF FOUR MDRS FOR THIS EVENT. FOUR 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS FOUR DEVICES WERE INVOLVED. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER (B)(4) AND REPORT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25337098 ↗
• MalfunctionMay 29, 2026Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED VITROS LACTATE (LAC) RESULTS WERE OBTAINED FROM A SINGLE LEVEL OF NON-VITROS BIORAD MULTIQUAL UNASSAYED CONTROLS, LOT 45980, AND A SINGLE LEVEL OF VITROS PERFORMANCE VERIFIER (PV) FLUID USING VITROS LAC SLIDE LOT 3533-0131-6128 TESTED ON A VITROS XT7600 INTEGRATED SYSTEM. BIORAD LEVEL 2 VITROS LAC RESULTS OF 2.66, 2.53, 2.63, 2.71, 2.54, 2.52 AND 2.55 MMOL/L VS. THE BASELINE MEAN VALUE OF 3.22 MMOL/L VITROS PV II, LOT D2338 VITROS LAC RESULTS OF 2.71 AND 2.87 MMOL/L VS. THE RANGE OF MEANS MIDPOINT VALUE OF 3.76 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 LAC RESULTS WERE OBTAINED FROM NON-PATIENT QUALITY CONTROL FLUIDS. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THE EVENT. THIS REPORT IS NUMBER TWO OF FOUR MDRS FOR THIS EVENT. FOUR 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS FOUR DEVICES WERE INVOLVED. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER (B)(4) AND REPORTA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25337082 ↗
• MalfunctionMay 29, 2026Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED VITROS LACTATE (LAC) RESULTS WERE OBTAINED FROM A SINGLE LEVEL OF NON-VITROS BIORAD MULTIQUAL UNASSAYED CONTROLS, LOT 45980, AND A SINGLE LEVEL OF VITROS PERFORMANCE VERIFIER (PV) FLUID USING VITROS LAC SLIDE LOT 3533-0131-6128 TESTED ON A VITROS XT7600 INTEGRATED SYSTEM. BIORAD LEVEL 2 VITROS LAC RESULTS OF 2.66, 2.53, 2.63, 2.71, 2.54, 2.52 AND 2.55 MMOL/L VS. THE BASELINE MEAN VALUE OF 3.22 MMOL/L VITROS PV II, LOT D2338 VITROS LAC RESULTS OF 2.71 AND 2.87 MMOL/L VS. THE RANGE OF MEANS MIDPOINT VALUE OF 3.76 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 LAC RESULTS WERE OBTAINED FROM NON-PATIENT QUALITY CONTROL FLUIDS. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THE EVENT. THIS REPORT IS NUMBER THREE OF FOUR MDRS FOR THIS EVENT. FOUR 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS FOUR DEVICES WERE INVOLVED. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER (B)(4) AND REPOR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25337058 ↗
• MalfunctionMay 29, 2026Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED VITROS LACTATE (LAC) RESULTS WERE OBTAINED FROM A SINGLE LEVEL OF NON-VITROS BIORAD MULTIQUAL UNASSAYED CONTROLS, LOT 45980, AND A SINGLE LEVEL OF VITROS PERFORMANCE VERIFIER (PV) FLUID USING VITROS LAC SLIDE LOT 3533-0131-6128 TESTED ON A VITROS XT7600 INTEGRATED SYSTEM. BIORAD LEVEL 2 VITROS LAC RESULTS OF 2.66, 2.53, 2.63, 2.71, 2.54, 2.52 AND 2.55 MMOL/L VS. THE BASELINE MEAN VALUE OF 3.22 MMOL/L VITROS PV II, LOT D2338 VITROS LAC RESULTS OF 2.71 AND 2.87 MMOL/L VS. THE RANGE OF MEANS MIDPOINT VALUE OF 3.76 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 LAC RESULTS WERE OBTAINED FROM NON-PATIENT QUALITY CONTROL FLUIDS. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THE EVENT. THIS REPORT IS NUMBER ONE OF FOUR MDRS FOR THIS EVENT. FOUR 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS FOUR DEVICES WERE INVOLVED. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER (B)(4) AND REPORTA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25337000 ↗
• MalfunctionJul 29, 2025High Test Results; High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED CALCIUM RESULTS WERE OBTAINED FROM QUALITY CONTROL (QC) FLUIDS PROCESSED USING VITROS CALCIUM (CA) SLIDE LOT: 0369-0700-8801 ON A VITROS 5600 INTEGRATED SYSTEM. MAS OMNI CORE (LOT: OCR2608) LEVEL 1 = 12.99, 12.78, 12.34, 12.11 VERSUS BASELINE MEAN 6.82 MG/DL 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 CA RESULTS WERE OBTAINED FROM QUALITY CONTROL FLUIDS. HOWEVER, THE INVESTIGATION CANNOT CONCLUDE THAT PATIENT RESULTS WOULD NOT BE AFFECTED IF THE EVENT WERE TO RECUR UNDETECTED. 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 22642103 ↗
• MalfunctionJul 2, 2025High Test Results; High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A HIGHER-THAN-EXPECTED VITROS CREA RESULT WAS OBTAINED FROM VITROS PERFORMANCE VERIFIER (PV) I USING VITROS CREATININE (CREA) SLIDE LOT 1515-3568-9503 TESTED ON A VITROS 250 CHEMISTRY SYSTEM. VITROS PV I LOT B2245 VITROS CREA RESULT OF 1.63 MG/DL VS. THE VITROS RANGE OF MEAN MIDPOINT PEER VALUE OF 1.03 MG/DL. 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 CREA RESULT WAS OBTAINED FROM A NON-PATIENT QUALITY CONTROL FLUID, HOWEVER, THE INVESTIGATION COULD NOT RULE OUT THAT PATIENT SAMPLES WOULD NOT BE AFFECTED IF THE EVENT WERE TO RECUR UNDETECTED. THERE WAS NO ALLEGATION 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 611162.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22381986 ↗
• MalfunctionJun 18, 2025High Test Results; High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A HIGHER-THAN-EXPECTED LACTATE RESULT WAS OBTAINED FROM A PATIENT SAMPLE PROCESSED DURING A REAGENT LOT TO LOT CORRELATION USING VITROS CHEMISTRY PRODUCTS LACTATE (LAC) SLIDES LOT 3533-0130-3002 ON A VITROS XT 7600 INTEGRATED SYSTEM. PATIENT SAMPLE RESULT OF 11.5 MMOL/L VS AN EXPECTED RESULT OF 9.9 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 LAC RESULT WAS OBTAINED DURING A REAGENT LOT TO LOT CORRELATION AND 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 22282912 ↗
• MalfunctionApr 22, 2025High Test Results; High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED VITROS GLUCOSE (GLU) RESULTS WERE OBTAINED FROM A SINGLE LEVEL OF NON-VITROS BIORAD MULTIQUAL LOT 46010 CONTROL TESTED ON A VITROS 5600 INTEGRATED SYSTEM. BIORAD MULTIQUAL LOT 46010 LEVEL 3 VITROS GLU RESULTS OF 613.2, 612.2, 614.3, 613.3, 611.5, 611.4 AND 612.5 MG/DL VS. THE EXPECTED RESULT OF 344.21 MG/DL 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 GLU RESULTS WERE OBTAINED FROM NON-PATIENT QUALITY CONTROL SAMPLES. THERE WAS 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 21886627 ↗
• MalfunctionApr 22, 2025High Test Results; High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED VITROS GLUCOSE (GLU) RESULTS WERE OBTAINED FROM A SINGLE LEVEL OF NON-VITROS BIORAD MULTIQUAL LOT: 46010 CONTROL TESTED ON A VITROS 5600 INTEGRATED SYSTEM. BIORAD MULTIQUAL LOT: 46010 LEVEL 3 VITROS GLU RESULTS OF 613.2, 612.2, 614.3, 613.3, 611.5, 611.4 AND 612.5 MG/DL VS. THE EXPECTED RESULT OF 344.21 MG/DL 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 GLU RESULTS WERE OBTAINED FROM NON-PATIENT QUALITY CONTROL SAMPLES. THERE WAS 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)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21886609 ↗
• MalfunctionFeb 20, 2025High Test Results; High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED LACTATE RESULTS WERE OBTAINED FROM NON-VITROS BIORAD QUALITY CONTROL FLUIDS PROCESSED USING VITROS CHEMISTRY PRODUCTS LAC SLIDES LOT 3533-0127-7634 ON A VITROS XT 7600 INTEGRATED SYSTEM. CAL ID 6104 OBTAINED USING VITROS CAL KIT 0194: BIORAD LOT 56730 LEVEL 1 RESULTS OF 2.64, 2.63, 2.66, 2.58, 2.60, 2.66 AND 2.66 MMOL/L VS AN EXPECTED RESULT OF 1.351 MMOL/L BIORAD LOT 56730 LEVEL 3 RESULTS OF 10.51, 10.50, 10.56, 10.36, 10.52, 10.65 AND 10.73 MMOL/L VS AN EXPECTED RESULT OF 5.28 MMOL/L CAL ID 6105 OBTAINED USING VITROS CAL KIT 0114: BIORAD LOT 56730 LEVEL 1 RESULTS OF 2.52 AND 2.51 MMOL/L VS AN EXPECTED RESULT OF 1.351 MMOL/L BIORAD LOT 56730 LEVEL 3 RESULT OF 10.76 MMOL/L VS AN EXPECTED RESULT OF 5.28 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 LAC RESULTS WERE OBTAINED FROM QUALITY CONTROL FLUIDS AND NO RESULTS WERE REPORTED FROM THE LABORATORY. THE CUSTOMER CONFIRMED THAT NO PATIENT SAMPLES WERE PROCESSED USING VIT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21425662 ↗
• MalfunctionFeb 20, 2025High Test Results; High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED LACTATE RESULTS WERE OBTAINED FROM NON-VITROS BIORAD QUALITY CONTROL FLUIDS PROCESSED USING VITROS CHEMISTRY PRODUCTS LAC SLIDES LOT 3533-0127-7634 ON A VITROS XT 7600 INTEGRATED SYSTEM. CAL ID 6104 OBTAINED USING VITROS CAL KIT 0194: BIORAD LOT 56730 LEVEL 1 RESULTS OF 2.64, 2.63, 2.66, 2.58, 2.60, 2.66 AND 2.66 MMOL/L VS AN EXPECTED RESULT OF 1.351 MMOL/L BIORAD LOT 56730 LEVEL 3 RESULTS OF 10.51, 10.50, 10.56, 10.36, 10.52, 10.65 AND 10.73 MMOL/L VS AN EXPECTED RESULT OF 5.28 MMOL/L CAL ID 6105 OBTAINED USING VITROS CAL KIT 0114: BIORAD LOT 56730 LEVEL 1 RESULTS OF 2.52 AND 2.51 MMOL/L VS AN EXPECTED RESULT OF 1.351 MMOL/L BIORAD LOT 56730 LEVEL 3 RESULT OF 10.76 MMOL/L VS AN EXPECTED RESULT OF 5.28 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 LAC RESULTS WERE OBTAINED FROM QUALITY CONTROL FLUIDS AND NO RESULTS WERE REPORTED FROM THE LABORATORY. THE CUSTOMER CONFIRMED THAT NO PATIENT SAMPLES WERE PROCESSED USING VIT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21425619 ↗
• MalfunctionNov 26, 2024High Test Results; High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A HIGHER-THAN-EXPECTED CALCIUM (CA) RESULT WAS OBTAINED FROM A NON-VITROS BIORAD QUALITY CONTROL FLUID USING VITROS CHEMISTRY PRODUCTS CA SLIDES LOT 0356-0683-4072 ON A VITROS 5600 INTEGRATED SYSTEM. BIORAD LOT 45960 LEVEL 1 RESULT OF 9.64 MG/DL VS. THE EXPECTED RESULT OF 5.85 MG/DL 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 CA RESULT WAS OBTAINED FROM A QUALITY CONTROL FLUID AND NO RESULTS WERE REPORTED FROM THE LABORATORY. NO PATIENT SAMPLES HAD BEEN PROCESSED USING THE VITROS CA REAGENT LOT. 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 20785685 ↗
• MalfunctionAug 22, 2024High Test Results; High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED VITROS CREATININE (CREA) RESULTS WERE OBTAINED FROM VITROS PERFORMANCE VERIFIER (PV) I USING VITROS CREA SLIDE LOT 1506-3546-8441 TESTED ON A VITROS XT 3400 CHEMISTRY SYSTEM. VITROS PV I LOT Q1174 VITROS CREA RESULT OF 1.52, 1.53, AND 1.53 MG/DL VS. THE VITROS RANGE OF MEAN MIDPOINT VALUE OF 1.03 MG/DL VITROS PV I LOT V1665 VITROS CREA RESULT OF 1.51 AND 1.55 MG/DL VS. THE EXPECTED VITROS RANGE OF MEAN MIDPOINT VALUE OF 0.92 MG/DL 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 CREA RESULTS WERE OBTAINED FROM A NON-PATIENT QUALITY CONTROL FLUID, HOWEVER, THE INVESTIGATION COULD NOT RULE OUT THAT PATIENT SAMPLES WERE NOT OR WOULD NOT BE AFFECTED IF THE EVENT WERE TO RECUR UNDETECTED. THERE WAS NO ALLEGATION 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 607072.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20036337 ↗
• MalfunctionApr 25, 2024High Test Results; High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED VITROS LACTATE (LAC) RESULTS WERE OBTAINED WHEN PROCESSING NON-VITROS BIORAD QUALITY CONTROL FLUIDS AND VITROS PERFORMANCE VERIFIERS. BIORAD MULTIQUAL CONTROLS, LOT 56743, VITROS LAC RESULTS OF 7.52 AND 7.58 MMOL/L VERSUS THE BASELINE MEAN OF 5.39 MMOL/L VITROS PERFORMANCE VERIFIER 2, LOT U1398 VITROS LAC RESULTS OF 5.12 AND 5.16 MMOL/L VERSUS THE MIDPOINT OF THE RANGE OF MEANS 3.71 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 LAC RESULTS WERE OBTAINED WHEN PROCESSING QUALITY CONTROL FLUIDS. NO ALLEGATION OF PATIENT HARM HAS BEEN MADE AS A RESULT OF THE 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 19187882 ↗
• MalfunctionFeb 13, 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 CREATININE XT (CREAXT) RESULT WAS OBTAINED FROM A SINGLE BIORAD QUALITY CONTROL LEVEL USING VITROS CREAXT SLIDE LOT 7217-0015-5648 ON A VITROS XT 7600 INTEGRATED SYSTEM. BIORAD CONTROL LOT 56720 LEVEL 1 VITROS CREAXT RESULT OF 1.50 MG/DL VS. THE VITROS PEER MEAN RESULT OF 0.827 MG/DL. 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 CREAXT RESULT WAS OBTAINED FROM A NON-PATIENT QUALITY CONTROL FLUID. THERE WAS NO ALLEGATION 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 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18696393 ↗
• MalfunctionFeb 9, 2024High Test Results; High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED VITROS GLUCOSE (GLU) RESULTS WERE OBTAINED FROM TWO LEVELS OF VITROS PERFORMANCE VERIFIER (PV) FLUIDS PROCESSED USING VITROS CHEMISTRY PRODUCTS GLU SLIDES LOT 0029-3238-4869 AND 0029-3238-5414 ON A VITROS 4600 CHEMISTRY SYSTEM. PVI T1396 RESULTS OF 198.04 MG/DL VS THE EXPECTED RESULT OF 94.1 MG/DL VITROS PVII U1398 RESULTS OF 625.00, 574.50, 535.61, 534.98, 548.14, 562.12, 586.35, 536.23, 527.79, 542.95, 548.87, 555.68, 616.89, 493.07, 533.90 AND 536.26 MG/DL VS THE EXPECTED RESULT OF 285.3 MG/DL 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 QC RESULTS WERE 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 NUMBERS (B)(4) AND REPORTABILITY ASSESSMENT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18676012 ↗
• MalfunctionDec 20, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  A LABORATORY OPERATOR SUSTAINED A SMALL CUT TO THEIR HAND WHEN ATTEMPTING TO OPEN VIAL 2 OF VITROS CALIBRATOR KIT 1. THERE WAS NO ALLEGATION OF A SERIOUS OR LONG TERM PERMANENT INJURY. HOWEVER, THERE IS A POTENTIAL THAT THE OPERATOR MIGHT BE EXPOSED TO BLOOD BORNE PATHOGENS AND SHOULD BE CONSIDERED AS A SERIOUS INJURY. PER MEDICAL CONSULT FROM AN ORTHO MEDICAL SAFETY OFFICER: BASED ON THE SAFETY DATA SHEET, THERE IS A RISK OF ZOONOTIC INFECTION FROM CONTACT WITH ANIMAL BLOOD DERIVATIVES. ALTHOUGH THE MATERIALS FOR MAKING THE REAGENTS WERE TESTED NEGATIVE FOR BLOOD-BORNE PATHOGENS, NO TEST METHOD CAN ASSURE THAT THE PRODUCT IS COMPLETELY SAFE FROM POTENTIAL PATHOGENS. IN ADDITION, THERE MIGHT BE UNKNOWN PATHOGENS OR PATHOGENS THAT WERE NOT TESTED. SO, A DISEASE TRANSMISSION DUE TO THE EXPOSURE CANNOT BE EXCLUDED. THUS, THIS EVENT MEETS THE DEFINITION OF A SERIOUS INJURY DUE TO THE UNCERTAINTY OF INFECTION RISK. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER (B)(4) AND REPORTABILITY ASSESSMENT (B)(4).

  Patient problems: Laceration(s)

  MAUDE report 18367912 ↗
• MalfunctionJul 20, 2023Low Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED QUALITY CONTROL RESULTS WERE OBTAINED FROM VITROS PERFORMANCE VERIFIER II (PVII) FLUID LOT P9966 WHEN USING VITROS CHEMISTRY PRODUCTS GLU-CA XT (CAXT) SLIDE LOT 7418-0015-8943 AND CALIBRATOR KIT LOT 0152 ON A VITROS XT 7600 INTEGRATED SYSTEM. PVII LOT P9966 RESULT OF 9.87 MG/DL VERSUS THE EXPECTED RESULT OF 12.09 MG/DL BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. THE RESULT WAS OBTAINED FROM A NON-PATIENT CONTROL FLUID. THE CUSTOMER DID NOT PROCESS PATIENT SAMPLES DUE TO THE QUALITY CONTROL FLUID BEING LOWER THAN EXPECTED. 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 602568.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17361254 ↗
• MalfunctionJun 1, 2023Low Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED LACTATE (LAC) RESULTS WERE OBTAINED FROM COLLEGE OF AMERICAN PATHOLOGISTS (CAP) PROFICIENCY SAMPLES AND A NON-VITROS BIORAD QUALITY CONTROL FLUID USING VITROS CHEMISTRY PRODUCTS LAC SLIDES LOT 3534-0117-8020 ON A VITROS 5600 INTEGRATED SYSTEM. CAP SAMPLE (B)(6) RESULT OF 7.4 MMOL/L VS AN EXPECTED RESULT OF 8.90 MMOL/L CAP SAMPLE (B)(6) RESULT OF 3.0 MMOL/L VS AN EXPECTED RESULT OF 3.83 MMOL/L CAP SAMPLE (B)(6) RESULT OF 6.1 MMOL/L VS AN EXPECTED RESULT OF 7.56 MMOL/L CAP SAMPLE (B)(6) RESULT OF 2.6 MMOL/L VS AN EXPECTED RESULT OF 3.27 MMOL/L BIORAD LOT 45910 LEVEL 3 RESULTS OF 4.43, 4.49, 4.44, 4.41, 4.40, 4.47, 4.37, 4.36, 4.39, 4.58, 4.40, 4.40, 4.37, 4.46, 4.41, 4.36, 4.42, 4.48, 4.42, 4.61, 4.37, 4.36 AND 4.45 MMOL/L VS AN EXPECTED RESULT OF 5.45 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 LAC RESULTS WERE OBTAINED FROM PROFICIENCY SAMPLES AND A NON-VITROS QUALITY CONTROL FLUID. THE CUSTOMER DID NOT INFORM ORTHO THA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17039130 ↗
• MalfunctionJun 1, 2023High Test Results; High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A HIGH VITROS CREATININE (CREA) RESULT OUTSIDE THE REFERENCE INTERVAL WAS OBTAINED FROM A SINGLE PATIENT SAMPLE USING VITROS CHEMISTRY PRODUCTS CREA SLIDES LOT 1501-3533-9930 ON A VITROS 5600 INTEGRATED SYSTEM. THE RESULT WAS HIGHER THAN EXPECTED WHEN COMPARED TO A REPEAT TEST EVENT OF THE SAME SAMPLE RUN ON A NEW CALIBRATION EVENT. PATIENT SAMPLE VITROS CREA RESULT OF 1.68 MG/DL VERSUS AN EXPECTED RESULT OF 1.37 MG/DL 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 CREA PATIENT 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 602040.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17037150 ↗
• MalfunctionMay 10, 2023High Test Results; High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A HIGHER THAN EXPECTED CALCIUM (CA) RESULT WAS OBTAINED FROM A NON-VITROS MAS QUALITY CONTROL FLUID PROCESSED USING VITROS CHEMISTRY PRODUCTS CA SLIDES LOT 0329-0641-4072 ON A VITROS XT 7600 INTEGRATED SYSTEM. MAS OMNI-CORE LOT 2406 LEVEL 1 RESULT OF 106.7 MG/L VS. THE EXPECTED RESULT OF 61.9 MG/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 CA 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 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16905451 ↗
• MalfunctionFeb 8, 2023High Test Results; High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED CALCIUM (CA) RESULTS WERE OBTAINED FROM A NON-VITROS MAS QUALITY CONTROL FLUID USING VITROS CHEMISTRY PRODUCTS CA SLIDES, LOT 0328-0640-3263, ON A VITROS 5600 INTEGRATED SYSTEM. MAS OMNI-CORE, LOT 2406, LEVEL 1 RESULTS OF 9.96, 10.16 AND 10.53 MG/DL VS. THE EXPECTED RESULT OF 6.13 MG/DL 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 CA RESULTS WERE OBTAINED FROM A QUALITY CONTROL FLUID AND NO RESULTS WERE 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 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16321483 ↗