VITROS 8058232Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10758750004294), received between Feb 17, 2023 and Mar 6, 2026 — classified as 9 malfunctions.

The most frequently reported specific device problem is “High Test Results” (7 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 6, 2026High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED VITROS CKMB RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE USING VITROS CKMB SLIDE LOT 4926-0279-3243 ON A VITROS XT3400 INTEGRATED SYSTEM, WHEN COMPARED TO RESULTS OBTAINED USING A NON-VITROS MASS SPECTROMETRY RESULT. PATIENT SAMPLE VITROS CKMB RESULT OF >1500 U/L VS. THE NON-VITROS RESULT OF 4.8 U/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 CKMB RESULT WAS NOT REPORTED FROM 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 24531044 ↗
• MalfunctionOct 22, 2025High Test Results; High Test Results

  AN INVESTIGATION BY ORTHO CLINICAL DIAGNOSTICS (ORTHO) DETERMINED HIGHER THAN EXPECTED VITROS CKMB RESULTS WERE OBTAINED FROM TWO DIFFERENT PATIENT CORRELATION SAMPLES USING VITROS CKMB SLIDE LOT: 4915-0261-6318 WHEN COMPARED TO VITROS CKMB RESULTS OBTAINED FROM THE SAME SAMPLES USING VITROS CKMB SLIDE LOT: 4917-0264-0605. THE CORRELATION SAMPLES WERE TESTED ON THE SAME VITROS 4600 CHEMISTRY SYSTEM. CORRELATION SAMPLE12 VITROS CKMB SLIDE LOT: 4915-0261-6318 RESULT OF 18 U/L VS. THE VITROS CKMB SLIDE LOT: 4917-0264-0605 RESULT OF 4 U/L CORRELATION SAMPLE14 VITROS CKMB SLIDE LOT: 4915-0261-6318 RESULT OF 35 U/L VS. THE VITROS CKMB SLIDE LOT: 4917-0264-0605 RESULT OF <14 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 HIGHER-THAN-EXPECTED VITROS CKMB RESULTS WERE OBTAINED AS PART OF AN ORTHO INVESTIGATION AND WERE NOT REPORTED. 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 DIAGNOST

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23357690 ↗
• MalfunctionOct 21, 2025High Test Results; High Test Results

  AN INVESTIGATION BY ORTHO CLINICAL DIAGNOSTICS (ORTHO) DETERMINED HIGHER THAN EXPECTED VITROS CKMB RESULTS WERE OBTAINED FROM TWO DIFFERENT PATIENT CORRELATION SAMPLES USING VITROS CKMB SLIDE LOT 4915-0261-6318 WHEN COMPARED TO VITROS CKMB RESULTS OBTAINED FROM THE SAME SAMPLES USING VITROS CKMB SLIDE LOT 4917-0264-0605. THE CORRELATION SAMPLES WERE TESTED ON THE SAME VITROS 4600 CHEMISTRY SYSTEM. CORRELATION SAMPLE12 VITROS CKMB SLIDE LOT 4915-0261-6318 RESULT OF 18 U/L VS. THE VITROS CKMB SLIDE LOT 4917-0264-0605 RESULT OF 4 U/L CORRELATION SAMPLE14 VITROS CKMB SLIDE LOT 4915-0261-6318 RESULT OF 35 U/L VS. THE VITROS CKMB SLIDE LOT 4917-0264-0605 RESULT OF <14 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 HIGHER-THAN-EXPECTED VITROS CKMB RESULTS WERE OBTAINED AS PART OF AN ORTHO INVESTIGATION AND WERE NOT REPORTED. 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 IN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23351843 ↗
• MalfunctionJul 1, 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 VITROS CKMB RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE PROCESSED USING VITROS CHEMISTRY PRODUCTS CREATINE KINASE -MB (CKMB) SLIDES LOT 4924-0273-8928 ON A VITROS XT 3400 CHEMISTRY SYSTEM. PATIENT SAMPLE VITROS CKMB RESULT OF 3 U/L VS AN EXPECTED RESULT OF 25 U/L 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 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 22371255 ↗
• MalfunctionJul 11, 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 MULTIPLE SAMPLES FROM THE SAME PATIENT TESTED USING VITROS CHEMISTRY PRODUCTS CKMB SLIDES LOT 4917-0264-0584 ON A VITROS 5600 INTEGRATED SYSTEM. PATIENT 1 SAMPLE VITROS CKMB RESULT OF 10 U/L VS AN EXPECTED RESULT OF 17 U/L PATIENT 2 SAMPLE VITROS CKMB RESULT OF 3 U/L VS AN EXPECTED RESULT OF 25 U/L PATIENT 3 SAMPLE VITROS CKMB RESULT OF 15 U/L VS AN EXPECTED RESULT OF 29 U/L PATIENT 4 SAMPLE VITROS CKMB RESULT OF 10 U/L VS AN EXPECTED RESULT OF 29 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 REPORTED FROM THE LABORATORY. HOWEVER, NO TREATMENT WAS STOPPED, STARTED OR ALTERED BASED ON THE VITROS CKMB RESULTS. 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 19722955 ↗
• MalfunctionMar 7, 2023High Test Results; High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A HIGHER THAN EXPECTED VITROS CKMB RESULT WAS OBTAINED FROM A PATIENT SAMPLE PROCESSED DURING A REAGENT LOT TO LOT CORRELATION TEST USING VITROS CHEMISTRY PRODUCTS CKMB SLIDES LOT: 4912-0253-3587 ON A VITROS 5600 INTEGRATED SYSTEM. PATIENT 2 SAMPLE VITROS CKMB RESULT OF 28 U/L VS AN EXPECTED RESULT OF 16 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 HIGHER THAN EXPECTED PATIENT SAMPLE RESULT WAS OBTAINED DURING CORRELATION TESTING 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 601026.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16494766 ↗
• MalfunctionFeb 22, 2023High Test Results; High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A HIGHER THAN EXPECTED VITROS CKMB RESULT WAS OBTAINED FROM A PATIENT SAMPLE USING VITROS CKMB SLIDE, LOT 4912-0254-4854, ON A VITROS 5600 INTEGRATED SYSTEM. VITROS CKMB RESULT OF 40 U/L VERSUS THE EXPECTED RESULT OF 7 U/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 CKMB RESULT WAS OBTAINED DURING A PATIENT CORRELATION AND WAS 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 NUMBER (B)(4) AND REPORTABILITY ASSESSMENT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16416271 ↗
• MalfunctionFeb 17, 2023High Test Results; High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED VITROS CKMB RESULTS WERE OBTAINED FROM TWO DIFFERENT CORRELATION PATIENT SAMPLES USING VITROS CKMB SLIDE LOT 4910-0250-9984 ON A VITROS 5600 INTEGRATED SYSTEM, WHEN COMPARED TO RESULTS OBTAINED USING AN ALTERNATE VITROS CKMB SLIDE LOT. CORRELATION PATIENT SAMPLE 2 RESULT OF 28 U/L VS. THE EXPECTED RESULT OF 16 U/L CORRELATION PATIENT SAMPLE 3 RESULT OF 24 U/L VS. THE EXPECTED RESULT OF 16 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 HIGHER THAN EXPECTED VITROS CKMB RESULTS WERE OBTAINED DURING A PATIENT SAMPLE CORRELATION AND WAS NOT REPORTED FROM THE LABORATORY. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER ONE OF TWO MDR¿S FOR THIS EVENT. TWO 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS TWO DEVICES WERE INVOLVED. (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16397803 ↗
• MalfunctionFeb 17, 2023High Test Results; High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED VITROS CKMB RESULTS WERE OBTAINED FROM TWO DIFFERENT CORRELATION PATIENT SAMPLES USING VITROS CKMB SLIDE LOT 4910-0250-9984 ON A VITROS 5600 INTEGRATED SYSTEM, WHEN COMPARED TO RESULTS OBTAINED USING AN ALTERNATE VITROS CKMB SLIDE LOT. CORRELATION PATIENT SAMPLE 2 RESULT OF 28 U/L VS. THE EXPECTED RESULT OF 16 U/L CORRELATION PATIENT SAMPLE 3 RESULT OF 24 U/L VS. THE EXPECTED RESULT OF 16 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 HIGHER THAN EXPECTED VITROS CKMB RESULTS WERE OBTAINED DURING A PATIENT SAMPLE CORRELATION AND WAS NOT REPORTED FROM THE LABORATORY. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER TWO OF TWO MDR¿S FOR THIS EVENT. TWO 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS TWO DEVICES WERE INVOLVED. THIS REPORT CORRESPONDS TO (B)(4)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16397796 ↗