VITROS 8001133Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10758750004201), received between May 18, 2023 and Feb 19, 2026 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (10 reports).

1 FDA recall record name this device's identifier, 1 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. Dec 11, 2020Open, Classified

   VITROS Chemistry Products CKMB Slides Potential for Falsely Elevated Results Due to CK-MM Interference

   Z-0770-2021 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 19, 2026Low 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 A VITROS ISOENZYME PERFORMANCE VERIFIER (IPV) PROCESSED USING VITROS CHEMISTRY PRODUCTS CKMB SLIDES LOT 4922-0272-8370 ON A VITROS 350 CHEMISTRY SYSTEM. VITROS IPV I LOT Y2755 VITROS CKMB RESULTS OF 9.3, 13.8, 11.1, 7.8, 12.7, 10.7, 12.1, 9.7, 10.6, 12.3, 6.3, 15.0, 11.1, 15.1, 8.7, 8.7 AND 15.2 U/L VS AN EXPECTED RESULT OF 21.5 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 LOWER-THAN-EXPECTED RESULTS WERE FROM A NON-PATIENT CONTROL FLUID AND WERE NOT REPORTED FROM THE LABORATORY. THE CUSTOMER STATED THAT NO PATIENT SAMPLE RESULTS HAD BEEN PROCESSED DURING THE TIMEFRAME OF THE EVENT. 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 24392383 ↗
• MalfunctionSep 19, 2024Low 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 FOUR DIFFERENT CORRELATION PATIENT SAMPLES USING VITROS CKMB SLIDE LOT 4917-0268-4441 ON A VITROS 4600 CHEMISTRY SYSTEM, WHEN COMPARED TO RESULTS OBTAINED USING AN ALTERNATE VITROS CKMB SLIDE LOT. CORRELATION PATIENT SAMPLE 2 RESULT OF 16, 14 AND 15 AND U/L VS. THE EXPECTED RESULT OF 31 U/L CORRELATION PATIENT SAMPLE 3 RESULTS OF 14 AND 11 AND 11 U/L VS. THE EXPECTED RESULT OF 30 U/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 CKMB RESULTS WERE OBTAINED DURING A PATIENT SAMPLE CORRELATION AND WERE NOT REPORTED FROM THE LABORATORY. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER SIX OF SIX MDRS FOR THIS EVENT. SIX 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS SIX 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 20258737 ↗
• MalfunctionSep 19, 2024Low 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 FOUR DIFFERENT CORRELATION PATIENT SAMPLES USING VITROS CKMB SLIDE LOT 4917-0268-4441 ON A VITROS 4600 CHEMISTRY SYSTEM, WHEN COMPARED TO RESULTS OBTAINED USING AN ALTERNATE VITROS CKMB SLIDE LOT. CORRELATION PATIENT SAMPLE 2 RESULT OF 16, 14 AND 15 AND U/L VS. THE EXPECTED RESULT OF 31 U/L CORRELATION PATIENT SAMPLE 3 RESULTS OF 14 AND 11 AND 11 U/L VS. THE EXPECTED RESULT OF 30 U/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 CKMB RESULTS WERE OBTAINED DURING A PATIENT SAMPLE CORRELATION AND WERE NOT REPORTED FROM THE LABORATORY. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER FIVE OF SIX MDRS FOR THIS EVENT. SIX 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS SIX 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 20257306 ↗
• MalfunctionSep 19, 2024Low 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 FOUR DIFFERENT CORRELATION PATIENT SAMPLES USING VITROS CKMB SLIDE LOT 4917-0268-4441 ON A VITROS 4600 CHEMISTRY SYSTEM, WHEN COMPARED TO RESULTS OBTAINED USING AN ALTERNATE VITROS CKMB SLIDE LOT. CORRELATION PATIENT SAMPLE 2 RESULT OF 16, 14 AND 15 AND U/L VS. THE EXPECTED RESULT OF 31 U/L CORRELATION PATIENT SAMPLE 3 RESULTS OF 14 AND 11 AND 11 U/L VS. THE EXPECTED RESULT OF 30 U/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 CKMB RESULTS WERE OBTAINED DURING A PATIENT SAMPLE CORRELATION AND WERE NOT REPORTED FROM THE LABORATORY. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER FOUR OF SIX MDRS FOR THIS EVENT. SIX 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS SIX 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 20257094 ↗
• MalfunctionSep 19, 2024Low 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 FOUR DIFFERENT CORRELATION PATIENT SAMPLES USING VITROS CKMB SLIDE LOT 4917-0268-4441 ON A VITROS 4600 CHEMISTRY SYSTEM, WHEN COMPARED TO RESULTS OBTAINED USING AN ALTERNATE VITROS CKMB SLIDE LOT. CORRELATION PATIENT SAMPLE 2 RESULT OF 16, 14 AND 15 AND U/L VS. THE EXPECTED RESULT OF 31 U/L CORRELATION PATIENT SAMPLE 3 RESULTS OF 14 AND 11 AND 11 U/L VS. THE EXPECTED RESULT OF 30 U/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 CKMB RESULTS WERE OBTAINED DURING A PATIENT SAMPLE CORRELATION AND WERE NOT REPORTED FROM THE LABORATORY. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER THREE OF SIX MDRS FOR THIS EVENT. SIX 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS SIX 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 20256033 ↗
• MalfunctionSep 19, 2024Low 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 FOUR DIFFERENT CORRELATION PATIENT SAMPLES USING VITROS CKMB SLIDE LOT 4917-0268-4441 ON A VITROS 4600 CHEMISTRY SYSTEM, WHEN COMPARED TO RESULTS OBTAINED USING AN ALTERNATE VITROS CKMB SLIDE LOT. CORRELATION PATIENT SAMPLE 2 RESULT OF 16, 14 AND 15 AND U/L VS. THE EXPECTED RESULT OF 31 U/L CORRELATION PATIENT SAMPLE 3 RESULTS OF 14 AND 11 AND 11 U/L VS. THE EXPECTED RESULT OF 30 U/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 CKMB RESULTS WERE OBTAINED DURING A PATIENT SAMPLE CORRELATION AND WERE NOT REPORTED FROM THE LABORATORY. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER ONE OF SIX MDRS FOR THIS EVENT. SIX 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS SIX 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 20256005 ↗
• MalfunctionSep 19, 2024Low 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 FOUR DIFFERENT CORRELATION PATIENT SAMPLES USING VITROS CKMB SLIDE LOT 4917-0268-4441 ON A VITROS 4600 CHEMISTRY SYSTEM, WHEN COMPARED TO RESULTS OBTAINED USING AN ALTERNATE VITROS CKMB SLIDE LOT. CORRELATION PATIENT SAMPLE 2 RESULT OF 16, 14 AND 15 AND U/L VS. THE EXPECTED RESULT OF 31 U/L CORRELATION PATIENT SAMPLE 3 RESULTS OF 14 AND 11 AND 11 U/L VS. THE EXPECTED RESULT OF 30 U/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 CKMB RESULTS WERE OBTAINED DURING A PATIENT SAMPLE CORRELATION AND WERE NOT REPORTED FROM THE LABORATORY. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER TWO OF SIX MDRS FOR THIS EVENT. SIX 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS SIX 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 20255979 ↗
• MalfunctionMay 18, 2023Low 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 A RIQAS EXTERNAL QUALITY CONTROL FLUID AND FROM A VITROS ISOENZYME PERFORMANCE VERIFIER (PV) FLUID WHEN RUNNING VITROS CKMB LOT 4903-0248-4599 ON A VITROS 5600 INTEGRATED SYSTEM. VITROS CKMB RIQAS CYCLE 44 SAMPLE 1 RESULT OF 10.0 U/L VERSUS THE EXPECTED RESULT OF 19.098 U/L VITROS ISOENZYME PVI LOT M8776 RESULTS OF 12.82 AND 8.40 U/L VERSUS THE EXPECTED RESULT OF 20.5 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 MADE NO INDICATION THAT PATIENT RESULTS FROM THE TIME FRAME OF THE EVENT WERE IN QUESTION AND THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. ORTHO HAS NOT BEEN MADE AWARE OF ANY ALLEGATION OF HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER THREE OF THREE MDR¿S 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 ASSE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16952112 ↗
• MalfunctionMay 18, 2023Low 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 A RIQAS EXTERNAL QUALITY CONTROL FLUID AND FROM A VITROS ISOENZYME PERFORMANCE VERIFIER (PV) FLUID WHEN RUNNING VITROS CKMB LOT 4903-0248-4599 ON A VITROS 5600 INTEGRATED SYSTEM. VITROS CKMB RIQAS CYCLE 44 SAMPLE 1 RESULT OF 10.0 U/L VERSUS THE EXPECTED RESULT OF 19.098 U/L VITROS ISOENZYME PVI LOT M8776 RESULTS OF 12.82 AND 8.40 U/L VERSUS THE EXPECTED RESULT OF 20.5 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 MADE NO INDICATION THAT PATIENT RESULTS FROM THE TIME FRAME OF THE EVENT WERE IN QUESTION AND THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. ORTHO HAS NOT BEEN MADE AWARE OF ANY ALLEGATION OF HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER TWO OF THREE MDR¿S 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 ASSESS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16952073 ↗
• MalfunctionMay 18, 2023Low 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 A RIQAS EXTERNAL QUALITY CONTROL FLUID AND FROM A VITROS ISOENZYME PERFORMANCE VERIFIER (PV) FLUID WHEN RUNNING VITROS CKMB LOT 4903-0248-4599 ON A VITROS 5600 INTEGRATED SYSTEM. VITROS CKMB RIQAS CYCLE 44 SAMPLE 1 RESULT OF 10.0 U/L VERSUS THE EXPECTED RESULT OF 19.098 U/L VITROS ISOENZYME PVI LOT M8776 RESULTS OF 12.82 AND 8.40 U/L VERSUS THE EXPECTED RESULT OF 20.5 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 MADE NO INDICATION THAT PATIENT RESULTS FROM THE TIME FRAME OF THE EVENT WERE IN QUESTION AND THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. ORTHO HAS NOT BEEN MADE AWARE OF ANY ALLEGATION OF HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER ONE OF THREE MDR¿S 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 ASSESS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16952053 ↗