VITROS 1707801Recalls & reported problems

Summary

The FDA's MAUDE database contains 48 adverse event reports that list this exact device (DI 10758750009572), received between May 18, 2023 and May 5, 2026 — classified as 48 malfunctions.

The most frequently reported specific device problem is “Non Reproducible Results” (38 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. Jun 17, 2019Terminated

   Potentially Biased Results using VITROS Chemistry Products GLU Slides

   Z-2202-2019 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 48 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 5, 2026Low Test Results; Non Reproducible Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A NON-REPRODUCIBLE, LOWER THAN EXPECTED GLUCOSE (GLU) RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE PROCESSED USING VITROS CHEMISTRY PRODUCTS GLU SLIDES LOT 0045-3252-0233 ON A VITROS 5600 INTEGRATED SYSTEM. PATIENT SAMPLE RESULT OF 39.4 MG/DL VS AN EXPECTED RESULT OF 212.0 MG/DL BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE NON-REPRODUCIBLE, LOWER THAN EXPECTED VITROS GLU RESULT WAS 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) AND REPORTABILITY ASSESSMENT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25086948 ↗
• MalfunctionNov 21, 2025Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A NON-REPRODUCIBLE, LOWER THAN EXPECTED GLUCOSE (GLU) RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE PROCESSED USING VITROS CHEMISTRY PRODUCTS GLU SLIDES LOT 0002-3259-4363 ON A VITROS 5600 INTEGRATED SYSTEM. PATIENT SAMPLE RESULT OF 42.1 MG/DL VS AN EXPECTED RESULTS OF 282.2 AND 276.8 MG/DL BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LED TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE LOWER-THAN-EXPECTED VITROS GLU RESULT 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 23618636 ↗
• MalfunctionNov 18, 2025Low Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT MULTIPLE LOWER THAN EXPECTED VITROS GLUCOSE (GLU) RESULTS WERE OBTAINED FROM A SINGLE PATIENT SAMPLE TESTED ON A VITROS XT 3400 CHEMISTRY SYSTEM. PATIENT SAMPLE RESULTS OF 43.2, <20.0, 60.9, <20.0 AND <20.0 MG/DL VS. THE EXPECTED RESULT OF 300 MG/DL BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE LOWER-THAN-EXPECTED VITROS GLU RESULTS OF WERE NOT REPORTED OUTSIDE OF THE LABORATORY AND 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 23585521 ↗
• MalfunctionNov 5, 2025Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT NON-REPRODUCIBLE, LOWER THAN EXPECTED VITROS GLUCOSE (GLU) AND VITROS TSH RESULTS WERE OBTAINED WHEN A PATIENT SAMPLE WAS TESTED ON A VITROS 5600 INTEGRATED SYSTEM. EXPECTED RESULTS WERE OBTAINED FOR THE PATIENT SAMPLE UPON REPEAT TESTING OF THE SAME SAMPLE. VITROS GLU RESULT OF < 20M MD/DL VERSUS THE REPEAT RESULT OF 153.39 MG/DL VITROS TSH RESULT OF 0.028 MIU/L (HYPERTHYROID) VERSUS THE REPEAT RESULT OF 3.71 MIU/L (EUTHYROID) BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE NON-REPRODUCIBLE, LOWER THAN EXPECTED VITROS GLU RESULT WAS NOT REPORTED FROM THE LABORATORY. HOWEVER, THE NON-REPRODUCIBLE, LOWER THAN EXPECTED VITROS TSH RESULT WAS REPORTED FROM THE LABORATORY. A CORRECTED REPORT WAS LATER ISSUED AND NO TREATMENT WAS ALTERED, INITIATED OR STOPPED BASED ON THE REPORTED RESULTS. 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 REP

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23480582 ↗
• MalfunctionJul 2, 2025Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A NON-REPRODUCIBLE, LOWER THAN EXPECTED GLUCOSE RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE PROCESSED USING VITROS CHEMISTRY PRODUCTS GLUCOSE (GLU) SLIDES LOT 0027-3245-2918 ON A VITROS 250 CHEMISTRY SYSTEM. PATIENT SAMPLE RESULT OF 25 MG/DL VS AN EXPECTED RESULT OF 176 MG/DL BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE LOWER-THAN-EXPECTED VITROS GLU RESULT WAS REPORTED FROM THE LABORATORY AND QUESTIONED BY A PHYSICIAN. NO TREATMENT WAS INITIATED, ALTERED OR STOPPED BASED ON THE RESULT AND A CORRECTED REPORT WAS LATER ISSUED. 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 22382041 ↗
• MalfunctionJun 5, 2025Low Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A NON-REPRODUCIBLE, LOWER THAN EXPECTED GLUCOSE (GLU) RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE PROCESSED USING VITROS CHEMISTRY PRODUCTS GLU SLIDES LOT 0036-3248-5857 ON A VITROS 5600 INTEGRATED SYSTEM. PATIENT SAMPLE RESULT OF < 1.1 MMOL/L VS AN EXPECTED RESULT OF > 15.0 MMOL/L BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. IT IS UNKNOWN IF THE LOWER-THAN-EXPECTED VITROS GLU RESULT OF < 1.1 MIU/ML WAS REPORTED OUTSIDE OF THE LABORATORY OR IF A CORRECT REPORT WAS ISSUED. 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 22151140 ↗
• MalfunctionApr 3, 2025Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  AN ORTHO CLINICAL DIAGNOSTICS (ORTHO) FIELD APPLICATION SPECIALIST (FAS) CONTACTED THE ORTHO TECHNICAL SOLUTIONS CENTER (TSC) ON BEHALF OF A CUSTOMER TO REPORT A NON-REPRODUCIBLE, LOWER THAN EXPECTED GLUCOSE (GLU) RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE PROCESSED USING VITROS CHEMISTRY PRODUCTS GLU SLIDES LOT 0036-3248-5953 ON A VITROS 5600 INTEGRATED SYSTEM. PATIENT SAMPLE RESULT OF 2.42 MMOL/L VS AN EXPECTED RESULT OF 12.88 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 VITROS GLU RESULT 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 21761631 ↗
• MalfunctionMar 7, 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 NON-REPRODUCIBLE, HIGHER THAN EXPECTED VITROS GLUCOSE (GLU) RESULTS WERE OBTAINED FROM A SINGLE PATIENT SAMPLE WHEN COMPARED TO THE VITROS GLU RESULT OBTAINED FROM A RETEST EVENT USING THE SAME PATIENT SAMPLE TESTED ON A VITROS XT 7600 INTEGRATED SYSTEM. PATIENT SAMPLE RESULTS OF 491.6, 233.5, AND 240.2 MG/DL VS THE EXPECTED RESULT OF 125.7 MG/DL BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE NON-REPRODUCIBLE, HIGHER THAN EXPECTED VITROS GLU RESULT OF 491.6 MG/DL WAS REPORTED FROM THE LABORATORY AND QUESTIONED BY A PHYSICIAN. THE SAMPLE WAS REPROCESSED AND A CORRECTED REPORT WAS LATER ISSUED. IT IS UNKNOWN IF TREATMENT WAS INITIATED, ALTERED OR STOPPED BASED ON THE NON-REPRODUCIBLE, HIGHER THAN EXPECTED RESULT THAT WAS RELEASED. THERE HAVE BEEN NO REPORTED ALLEGATIONS 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 DIAGNOSTIC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21547111 ↗
• MalfunctionMar 7, 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 NON-REPRODUCIBLE, HIGHER THAN EXPECTED VITROS GLUCOSE (GLU) RESULTS WERE OBTAINED FROM A SINGLE PATIENT SAMPLE WHEN COMPARED TO THE VITROS GLU RESULT OBTAINED FROM A RETEST EVENT USING THE SAME PATIENT SAMPLE TESTED ON A VITROS XT 7600 INTEGRATED SYSTEM. PATIENT SAMPLE RESULTS OF 491.6, 233.5, AND 240.2 MG/DL VS THE EXPECTED RESULT OF 125.7 MG/DL BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE NON-REPRODUCIBLE, HIGHER THAN EXPECTED VITROS GLU RESULT OF 491.6 MG/DL WAS REPORTED FROM THE LABORATORY AND QUESTIONED BY A PHYSICIAN. THE SAMPLE WAS REPROCESSED AND A CORRECTED REPORT WAS LATER ISSUED. IT IS UNKNOWN IF TREATMENT WAS INITIATED, ALTERED OR STOPPED BASED ON THE NON-REPRODUCIBLE, HIGHER THAN EXPECTED RESULT THAT WAS RELEASED. THERE HAVE BEEN NO REPORTED ALLEGATIONS 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 DIAGNOSTIC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21546589 ↗
• MalfunctionFeb 10, 2025Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A NON-REPRODUCIBLE, LOWER THAN EXPECTED GLUCOSE (GLU) RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE PROCESSED USING VITROS CHEMISTRY PRODUCTS GLU SLIDES LOT: 0027-3245-3307 ON A VITROS 5600 INTEGRATED SYSTEM. PATIENT SAMPLE RESULT OF < 20 MG/DL VS AN EXPECTED RESULT OF 180.2 MG/DL BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE LOWER-THAN-EXPECTED VITROS GLU RESULT WAS REPORTED FROM THE LABORATORY AND QUESTIONED BY A PHYSICIAN. NO TREATMENT WAS INITIATED, ALTERED OR STOPPED BASED ON THE RESULT AND A CORRECTED REPORT WAS LATER ISSUED. 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).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21347037 ↗
• MalfunctionOct 30, 2024Low Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED GLUCOSE (GLU) AND ACETAMINOPHEN (ACET) RESULTS WERE OBTAINED FROM A NON-VITROS BIORAD QUALITY CONTROL PROCESSED USING VITROS CHEMISTRY PRODUCTS GLU SLIDES LOT 0034-3244-1334, VITROS CHEMISTRY PRODUCTS ACET SLIDES LOT 2917-0076-0072 ON A VITROS 5600 INTEGRATED SYSTEM. VITROS GLU: BIORAD LOT 45980 LEVEL 3 RESULTS OF 109.92 AND <20 MG/DL VS THE EXPECTED RESULT OF 345 MG/DL VITROS ACET: BIORAD LOT 45980 LEVEL 3 RESULT OF <10 UG/ML VS THE EXPECTED RESULT OF 128.69 UG/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 ASSAY RESULTS WERE OBTAINED FROM CONTROL FLUIDS AND WERE NOT REPORTED FROM THE LABORATORY. THE CUSTOMER DID NOT INDICATE THAT PATIENT SAMPLES HAD BEEN AFFECTED. THERE HAS BEEN NO REPORTED 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 DIAGNOS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20571379 ↗
• MalfunctionFeb 9, 2024Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT NON-REPRODUCIBLE, LOWER THAN EXPECTED GLUCOSE (GLU) RESULTS WERE OBTAINED FROM A MULTIPLE PATIENT SAMPLES PROCESSED USING VITROS CHEMISTRY PRODUCTS GLU SLIDES LOT 0023-3233-9483 ON A VITROS 250 CHEMISTRY SYSTEM. PATIENT 2 SAMPLE RESULT OF <10.0 MG/DL VS THE EXPECTED RESULT OF 192.0 MG/DL PATIENT 4 SAMPLE RESULT OF <10.0 MG/DL VS THE EXPECTED RESULT OF 170.0 MG/DL PATIENT 5 SAMPLE RESULT OF <10.0 MG/DL VS THE EXPECTED RESULT OF 186.0 MG/DL BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE LOWER THAN EXPECTED VITROS GLU RESULTS WERE NOT REPORTED FROM THE LABORATORY. NO TREATMENT WAS ADMINISTERED BASED ON ANY LOWER THAN EXPECTED RESULTS OBTAINED. THERE WAS 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 NUMBER (B)(4) AND REPORTABILITY ASSESSMENT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18676353 ↗
• MalfunctionFeb 9, 2024Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT NON-REPRODUCIBLE, LOWER THAN EXPECTED GLUCOSE (GLU) RESULTS WERE OBTAINED FROM A MULTIPLE PATIENT SAMPLES PROCESSED USING VITROS CHEMISTRY PRODUCTS GLU SLIDES LOT 0023-3233-9483 ON A VITROS 250 CHEMISTRY SYSTEM. PATIENT 2 SAMPLE RESULT OF <10.0 MG/DL VS THE EXPECTED RESULT OF 192.0 MG/DL PATIENT 4 SAMPLE RESULT OF <10.0 MG/DL VS THE EXPECTED RESULT OF 170.0 MG/DL PATIENT 5 SAMPLE RESULT OF <10.0 MG/DL VS THE EXPECTED RESULT OF 186.0 MG/DL BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE LOWER THAN EXPECTED VITROS GLU RESULTS WERE NOT REPORTED FROM THE LABORATORY. NO TREATMENT WAS ADMINISTERED BASED ON ANY LOWER THAN EXPECTED RESULTS OBTAINED. THERE WAS 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 NUMBER (B)(4) AND REPORTABILITY ASSESSMENT (B)(4) .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18676127 ↗
• MalfunctionFeb 9, 2024Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT NON-REPRODUCIBLE, LOWER THAN EXPECTED GLUCOSE (GLU) RESULTS WERE OBTAINED FROM A MULTIPLE PATIENT SAMPLES PROCESSED USING VITROS CHEMISTRY PRODUCTS GLU SLIDES LOT 0023-3233-9483 ON A VITROS 250 CHEMISTRY SYSTEM. PATIENT 2 SAMPLE RESULT OF <10.0 MG/DL VS THE EXPECTED RESULT OF 192.0 MG/DL PATIENT 4 SAMPLE RESULT OF <10.0 MG/DL VS THE EXPECTED RESULT OF 170.0 MG/DL PATIENT 5 SAMPLE RESULT OF <10.0 MG/DL VS THE EXPECTED RESULT OF 186.0 MG/DL BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE LOWER THAN EXPECTED VITROS GLU RESULTS WERE NOT REPORTED FROM THE LABORATORY. NO TREATMENT WAS ADMINISTERED BASED ON ANY LOWER THAN EXPECTED RESULTS OBTAINED. THERE WAS 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 NUMBER (B)(4) AND REPORTABILITY ASSESSMENT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18676048 ↗
• MalfunctionSep 29, 2023Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A NON-REPRODUCIBLE, LOWER THAN EXPECTED GLUCOSE (GLU) RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE PROCESSED USING VITROS CHEMISTRY PRODUCTS GLU SLIDES LOT 0023-3233-9322 ON A VITROS 5,1 CHEMISTRY SYSTEM. PATIENT SAMPLE RESULT OF 35.2 MG/DL VS THE EXPECTED RESULT OF 160.37 MG/DL BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. IT IS UNKNOWN IF THE LOWER THAN EXPECTED VITROS GLU RESULTS WERE REPORTED FROM THE LABORATORY, HOWEVER IT WAS CONFIRMED THAT NO TREATMENT WAS ADMINISTERED BASED ON ANY LOWER THAN EXPECTED RESULTS OBTAINED. 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 17848036 ↗
• MalfunctionSep 20, 2023High Test Results; High Test Results

  THE CUSTOMER REPORTED NON-REPRODUCIBLE, HIGHER THAN EXPECTED VITROS GLU RESULTS WERE OBTAINED FROM TWO DIFFERENT PATIENT SAMPLES TESTED ON A VITROS XT7600 INTEGRATED SYSTEM. PATIENT 1: VITROS GLU RESULTS OF >625, >1250, 402 MG/DL VS. THE EXPECTED RESULT OF 178.0 MG/DL. PATIENT 2: VITROS GLU RESULT OF >625, >1250 MG/DL VS. THE EXPECTED RESULT OF 68.0 MG/DL. BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED COULD LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. THE HIGHER THAN EXPECTED VITROS GLU PATIENT RESULTS WERE NOT REPORTED FROM THE LABORATORY. THERE WERE NO ALLEGATIONS OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER FIVE OF FIVE MDR¿S FOR THIS EVENT. FIVE 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS FIVE 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 17784387 ↗
• MalfunctionSep 20, 2023High Test Results; High Test Results

  THE CUSTOMER REPORTED NON-REPRODUCIBLE, HIGHER THAN EXPECTED VITROS GLU RESULTS WERE OBTAINED FROM TWO DIFFERENT PATIENT SAMPLES TESTED ON A VITROS XT7600 INTEGRATED SYSTEM. PATIENT 1: VITROS GLU RESULTS OF >625, >1250, 402 MG/DL VS. THE EXPECTED RESULT OF 178.0 MG/DL. PATIENT 2: VITROS GLU RESULT OF >625, >1250 MG/DL VS. THE EXPECTED RESULT OF 68.0 MG/DL. BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED COULD LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. THE HIGHER THAN EXPECTED VITROS GLU PATIENT RESULTS WERE NOT REPORTED FROM THE LABORATORY. THERE WERE NO ALLEGATIONS OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER FOUR OF FIVE MDR¿S FOR THIS EVENT. FIVE 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS FIVE DEVICES WERE INVOLVED. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER (B)(4). AND REPORTABILITY ASSESSMENT 603171.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17784248 ↗
• MalfunctionSep 20, 2023High Test Results; High Test Results

  THE CUSTOMER REPORTED NON-REPRODUCIBLE, HIGHER THAN EXPECTED VITROS GLU RESULTS WERE OBTAINED FROM TWO DIFFERENT PATIENT SAMPLES TESTED ON A VITROS XT7600 INTEGRATED SYSTEM. PATIENT 1: VITROS GLU RESULTS OF >625, >1250, 402 MG/DL VS. THE EXPECTED RESULT OF 178.0 MG/DL. PATIENT 2: VITROS GLU RESULT OF >625, >1250 MG/DL VS. THE EXPECTED RESULT OF 68.0 MG/DL. BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED COULD LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. THE HIGHER THAN EXPECTED VITROS GLU PATIENT RESULTS WERE NOT REPORTED FROM THE LABORATORY. THERE WERE NO ALLEGATIONS OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER THREE OF FIVE MDR¿S FOR THIS EVENT. FIVE 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS FIVE 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 17783416 ↗
• MalfunctionSep 20, 2023High Test Results; High Test Results

  THE CUSTOMER REPORTED NON-REPRODUCIBLE, HIGHER THAN EXPECTED VITROS GLU RESULTS WERE OBTAINED FROM TWO DIFFERENT PATIENT SAMPLES TESTED ON A VITROS XT7600 INTEGRATED SYSTEM. PATIENT 1: VITROS GLU RESULTS OF >625, >1250, 402 MG/DL VS. THE EXPECTED RESULT OF 178.0 MG/DL. PATIENT 2: VITROS GLU RESULT OF >625, >1250 MG/DL VS. THE EXPECTED RESULT OF 68.0 MG/DL. BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED COULD LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. THE HIGHER THAN EXPECTED VITROS GLU PATIENT RESULTS WERE NOT REPORTED FROM THE LABORATORY. THERE WERE NO ALLEGATIONS OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER TWO OF FIVE MDR¿S FOR THIS EVENT. FIVE 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS FIVE 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 17783391 ↗
• MalfunctionSep 20, 2023High Test Results; High Test Results

  THE CUSTOMER REPORTED NON-REPRODUCIBLE, HIGHER THAN EXPECTED VITROS GLU RESULTS WERE OBTAINED FROM TWO DIFFERENT PATIENT SAMPLES TESTED ON A VITROS XT7600 INTEGRATED SYSTEM. PATIENT 1: VITROS GLU RESULTS OF >625, >1250, 402 MG/DL VS. THE EXPECTED RESULT OF 178.0 MG/DL. PATIENT 2: VITROS GLU RESULT OF >625, >1250 MG/DL VS. THE EXPECTED RESULT OF 68.0 MG/DL. BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED COULD LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. THE HIGHER THAN EXPECTED VITROS GLU PATIENT RESULTS WERE NOT REPORTED FROM THE LABORATORY. THERE WERE NO ALLEGATIONS OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER ONE OF FIVE MDR¿S FOR THIS EVENT. FIVE 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS FIVE 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 17783186 ↗
• MalfunctionSep 6, 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 NON-REPRODUCIBLE, HIGHER THAN EXPECTED VITROS GLUCOSE (GLU) RESULTS WERE OBTAINED FROM TEN DIFFERENT PATIENT SAMPLES TESTED ON A VITROS XT7600 INTEGRATED SYSTEM. PATIENT SAMPLE 1: VITROS GLU RESULT OF >625 MG/DL VS. THE REPEAT RESULT OF 75 MG/DL PATIENT SAMPLE 2: VITROS GLU RESULT OF >625 MG/DL VS. THE REPEAT RESULT OF 132 MG/DL PATIENT SAMPLE 3: VITROS GLU RESULT OF >625 MG/DL VS. THE REPEAT RESULT OF 150 MG/DL PATIENT SAMPLE 4: VITROS GLU RESULT OF >625 MG/DL VS. THE REPEAT RESULT OF 79 MG/DL PATIENT SAMPLE 5: VITROS GLU RESULT OF >625 MG/DL VS. THE REPEAT RESULT OF 136 MG/DL PATIENT SAMPLE 6: VITROS GLU RESULT OF >625 MG/DL VS. THE REPEAT RESULT OF 109 MG/DL PATIENT SAMPLE 7: VITROS GLU RESULT OF >625 MG/DL VS. THE REPEAT RESULT OF 114 MG/DL PATIENT SAMPLE 8: VITROS GLU RESULT OF >625 MG/DL VS. THE REPEAT RESULT OF 80 MG/DL PATIENT SAMPLE 9: VITROS GLU RESULT OF >625 MG/DL VS. THE REPEAT RESULT OF 95 MG/DL PATIENT SAMPLE 10: VITROS GLU RESULT OF >625 MG/DL VS. THE REPEAT RESULT OF 166 MG/DL BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17691659 ↗
• MalfunctionSep 6, 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 NON-REPRODUCIBLE, HIGHER THAN EXPECTED VITROS GLUCOSE (GLU) RESULTS WERE OBTAINED FROM TEN DIFFERENT PATIENT SAMPLES TESTED ON A VITROS XT7600 INTEGRATED SYSTEM. PATIENT SAMPLE 1: VITROS GLU RESULT OF >625 MG/DL VS. THE REPEAT RESULT OF 75 MG/DL PATIENT SAMPLE 2: VITROS GLU RESULT OF >625 MG/DL VS. THE REPEAT RESULT OF 132 MG/DL PATIENT SAMPLE 3: VITROS GLU RESULT OF >625 MG/DL VS. THE REPEAT RESULT OF 150 MG/DL PATIENT SAMPLE 4: VITROS GLU RESULT OF >625 MG/DL VS. THE REPEAT RESULT OF 79 MG/DL PATIENT SAMPLE 5: VITROS GLU RESULT OF >625 MG/DL VS. THE REPEAT RESULT OF 136 MG/DL PATIENT SAMPLE 6: VITROS GLU RESULT OF >625 MG/DL VS. THE REPEAT RESULT OF 109 MG/DL PATIENT SAMPLE 7: VITROS GLU RESULT OF >625 MG/DL VS. THE REPEAT RESULT OF 114 MG/DL PATIENT SAMPLE 8: VITROS GLU RESULT OF >625 MG/DL VS. THE REPEAT RESULT OF 80 MG/DL PATIENT SAMPLE 9: VITROS GLU RESULT OF >625 MG/DL VS. THE REPEAT RESULT OF 95 MG/DL PATIENT SAMPLE 10: VITROS GLU RESULT OF >625 MG/DL VS. THE REPEAT RESULT OF 166 MG/DL BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17691593 ↗
• MalfunctionSep 6, 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 NON-REPRODUCIBLE, HIGHER THAN EXPECTED VITROS GLUCOSE (GLU) RESULTS WERE OBTAINED FROM TEN DIFFERENT PATIENT SAMPLES TESTED ON A VITROS XT7600 INTEGRATED SYSTEM. PATIENT SAMPLE 1: VITROS GLU RESULT OF >625 MG/DL VS. THE REPEAT RESULT OF 75 MG/DL, PATIENT SAMPLE 2: VITROS GLU RESULT OF >625 MG/DL VS. THE REPEAT RESULT OF 132 MG/DL, PATIENT SAMPLE 3: VITROS GLU RESULT OF >625 MG/DL VS. THE REPEAT RESULT OF 150 MG/DL, PATIENT SAMPLE 4: VITROS GLU RESULT OF >625 MG/DL VS. THE REPEAT RESULT OF 79 MG/DL, PATIENT SAMPLE 5: VITROS GLU RESULT OF >625 MG/DL VS. THE REPEAT RESULT OF 136 MG/DL, PATIENT SAMPLE 6: VITROS GLU RESULT OF >625 MG/DL VS. THE REPEAT RESULT OF 109 MG/DL, PATIENT SAMPLE 7: VITROS GLU RESULT OF >625 MG/DL VS. THE REPEAT RESULT OF 114 MG/DL, PATIENT SAMPLE 8: VITROS GLU RESULT OF >625 MG/DL VS. THE REPEAT RESULT OF 80 MG/DL, PATIENT SAMPLE 9: VITROS GLU RESULT OF >625 MG/DL VS. THE REPEAT RESULT OF 95 MG/DL, PATIENT SAMPLE 10: VITROS GLU RESULT OF >625 MG/DL VS. THE REPEAT RESULT OF 166 MG/DL. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIAT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17691517 ↗
• MalfunctionSep 6, 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 NON-REPRODUCIBLE, HIGHER THAN EXPECTED VITROS GLUCOSE (GLU) RESULTS WERE OBTAINED FROM TEN DIFFERENT PATIENT SAMPLES TESTED ON A VITROS XT7600 INTEGRATED SYSTEM. PATIENT SAMPLE 1: VITROS GLU RESULT OF >625 MG/DL VS. THE REPEAT RESULT OF 75 MG/DL PATIENT SAMPLE 2: VITROS GLU RESULT OF >625 MG/DL VS. THE REPEAT RESULT OF 132 MG/DL PATIENT SAMPLE 3: VITROS GLU RESULT OF >625 MG/DL VS. THE REPEAT RESULT OF 150 MG/DL PATIENT SAMPLE 4: VITROS GLU RESULT OF >625 MG/DL VS. THE REPEAT RESULT OF 79 MG/DL PATIENT SAMPLE 5: VITROS GLU RESULT OF >625 MG/DL VS. THE REPEAT RESULT OF 136 MG/DL PATIENT SAMPLE 6: VITROS GLU RESULT OF >625 MG/DL VS. THE REPEAT RESULT OF 109 MG/DL PATIENT SAMPLE 7: VITROS GLU RESULT OF >625 MG/DL VS. THE REPEAT RESULT OF 114 MG/DL PATIENT SAMPLE 8: VITROS GLU RESULT OF >625 MG/DL VS. THE REPEAT RESULT OF 80 MG/DL PATIENT SAMPLE 9: VITROS GLU RESULT OF >625 MG/DL VS. THE REPEAT RESULT OF 95 MG/DL PATIENT SAMPLE 10: VITROS GLU RESULT OF >625 MG/DL VS. THE REPEAT RESULT OF 166 MG/DL BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17691410 ↗
• MalfunctionSep 6, 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 NON-REPRODUCIBLE, HIGHER THAN EXPECTED VITROS GLUCOSE (GLU) RESULTS WERE OBTAINED FROM TEN DIFFERENT PATIENT SAMPLES TESTED ON A VITROS XT7600 INTEGRATED SYSTEM. PATIENT SAMPLE 1: VITROS GLU RESULT OF >625 MG/DL VS. THE REPEAT RESULT OF 75 MG/DL PATIENT SAMPLE 2: VITROS GLU RESULT OF >625 MG/DL VS. THE REPEAT RESULT OF 132 MG/DL PATIENT SAMPLE 3: VITROS GLU RESULT OF >625 MG/DL VS. THE REPEAT RESULT OF 150 MG/DL PATIENT SAMPLE 4: VITROS GLU RESULT OF >625 MG/DL VS. THE REPEAT RESULT OF 79 MG/DL PATIENT SAMPLE 5: VITROS GLU RESULT OF >625 MG/DL VS. THE REPEAT RESULT OF 136 MG/DL PATIENT SAMPLE 6: VITROS GLU RESULT OF >625 MG/DL VS. THE REPEAT RESULT OF 109 MG/DL PATIENT SAMPLE 7: VITROS GLU RESULT OF >625 MG/DL VS. THE REPEAT RESULT OF 114 MG/DL PATIENT SAMPLE 8: VITROS GLU RESULT OF >625 MG/DL VS. THE REPEAT RESULT OF 80 MG/DL PATIENT SAMPLE 9: VITROS GLU RESULT OF >625 MG/DL VS. THE REPEAT RESULT OF 95 MG/DL PATIENT SAMPLE 10: VITROS GLU RESULT OF >625 MG/DL VS. THE REPEAT RESULT OF 166 MG/DL BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17691366 ↗