VITROS 1450261Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10758750009114), received between Feb 26, 2025 and Sep 10, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (7 reports).

2 FDA recall records name this device's identifier, 2 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Recalls naming this device

1. Jul 9, 2025Open, Classified

   Generations 67 and above of VITROS Ca Slides are experiencing an increased occurrence of Condition Code TH4-63J during calibration on VITROS XT 3400 and VITROS XT 7600 Systems, causing calibration failures that delay calcium test results and potentially impact patient management. The imaging reflectometer algorithm detects excessive "spikes" (imperfections) in slide images and generates the TH4-63J condition code when the threshold of 600 spikes is exceeded. Updated analysis revealed a 19-fold increase in failure rates from 0.0043% (2024 baseline) to 0.082% for Generation 67+ slides in 2025, with 100% of calibrator failures occurring at the lowest concentration level. This can result in delayed diagnosis and treatment of conditions such as hypercalcemic crisis, parathyroid disorders, and other calcium-related emergencies requiring urgent intervention.

   Z-2335-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. Apr 24, 2025Open, Classified

   transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.

   Z-1831-2025 · Root cause: Storage · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 10, 2025Low Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A LOWER THAN EXPECTED VITROS CALCIUM (CA) RESULT WAS OBTAINED FROM A SINGLE QUALITY CONTROL LEVEL PROCESSED ON A VITROS XT 7600 INTEGRATED SYSTEM. BIORAD MULTIQUAL LEVEL 3 LOT 56760 RESULT OF 7.8 MG/DL VS THE EXPECTED RESULT OF 12.22 MG/DL BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. TWENTY-FOUR PATIENT SAMPLES WERE PROCESSED DURING THE TIMEFRAME OF THE EVENT AND GENERATED NEGATIVELY BIASED VITROS CA RESULTS. NONE OF THE NEGATIVELY BIASED RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. ALL 24 SAMPLES WERE RETESTED USING A SLIDE CARTRIDGE OTHER THAN THE AFFECTED CARTRIDGE, AND THE CUSTOMER CONSIDERED THE REPEAT RESULTS TO BE THE EXPECTED RESULTS FOR THE SAMPLES. THE CUSTOMER DID NOT PROVIDE ANY SPECIFIC DATA CONCERNING THE 24 AFFECTED 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 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23015562 ↗
• MalfunctionFeb 26, 2025Low Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED RESULTS WERE OBTAINED FROM VITROS CALCIUM (CA) SLIDE LOT: 0359-0685-5671 FROM A SINGLE LEVEL OF NON-THERMOFISHER MAS OMNICORE (MAS) CONTROLS, LOT: OCR2608 TESTED ON A VITROS 5600 INTEGRATED SYSTEM. MAS LEVEL 3 VITROS CA RESULTS OF 9.49, 9.44, 9.44, 9.69, 9.39 AND 6.14 MG/DL VS. THE EXPECTED RESULT OF 12.20 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 LOWER-THAN-EXPECTED VITROS CA RESULTS WERE OBTAINED FROM A NON-PATIENT QUALITY CONTROL FLUID. THERE WAS NO ALLEGATION OF 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).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21468325 ↗
• MalfunctionFeb 26, 2025Low Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED RESULTS WERE OBTAINED FROM VITROS CALCIUM (CA) SLIDE LOT 0359-0685-5671 FROM A SINGLE LEVEL OF NON-THERMOFISHER MAS OMNICORE (MAS) CONTROLS, LOT OCR2608 TESTED ON A VITROS 5600 INTEGRATED SYSTEM. MAS LEVEL 3 VITROS CA RESULTS OF 9.49, 9.44, 9.44, 9.69, 9.39 AND 6.14 MG/DL VS. THE EXPECTED RESULT OF 12.20 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 LOWER THAN EXPECTED VITROS CA RESULTS WERE OBTAINED FROM A NON-PATIENT QUALITY CONTROL FLUID. THERE WAS NO ALLEGATION OF 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 608996.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21468322 ↗
• MalfunctionFeb 26, 2025Low Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED RESULTS WERE OBTAINED FROM VITROS CALCIUM (CA) SLIDE LOT 0359-0685-5671 FROM A SINGLE LEVEL OF NON-THERMOFISHER MAS OMNICORE (MAS) CONTROLS, LOT OCR2608 TESTED ON A VITROS 5600 INTEGRATED SYSTEM. MAS LEVEL 3 VITROS CA RESULTS OF 9.49, 9.44, 9.44, 9.69, 9.39 AND 6.14 MG/DL VS. THE EXPECTED RESULT OF 12.20 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 LOWER-THAN-EXPECTED VITROS CA RESULTS WERE OBTAINED FROM A NON-PATIENT QUALITY CONTROL FLUID. THERE WAS NO ALLEGATION OF 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 21468321 ↗
• MalfunctionFeb 26, 2025Low Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED RESULTS WERE OBTAINED FROM VITROS CALCIUM (CA) SLIDE LOT 0359-0685-5671 FROM A SINGLE LEVEL OF NON-THERMOFISHER MAS OMNICORE (MAS) CONTROLS, LOT OCR2608 TESTED ON A VITROS 5600 INTEGRATED SYSTEM. MAS LEVEL 3 VITROS CA RESULTS OF 9.49, 9.44, 9.44, 9.69, 9.39 AND 6.14 MG/DL VS. THE EXPECTED RESULT OF 12.20 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 LOWER-THAN-EXPECTED VITROS CA RESULTS WERE OBTAINED FROM A NON-PATIENT QUALITY CONTROL FLUID. THERE WAS NO ALLEGATION OF 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 21468317 ↗
• MalfunctionFeb 26, 2025Low Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED RESULTS WERE OBTAINED FROM VITROS CALCIUM (CA) SLIDE LOT: 0359-0685-5671 FROM A SINGLE LEVEL OF NON-THERMOFISHER MAS OMNICORE (MAS) CONTROLS, LOT: OCR2608 TESTED ON A VITROS 5600 INTEGRATED SYSTEM. MAS LEVEL 3 VITROS CA RESULTS OF 9.49, 9.44, 9.44, 9.69, 9.39 AND 6.14 MG/DL VS. THE EXPECTED RESULT OF 12.20 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 LOWER-THAN-EXPECTED VITROS CA RESULTS WERE OBTAINED FROM A NON-PATIENT QUALITY CONTROL FLUID. THERE WAS NO ALLEGATION OF 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).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21468304 ↗
• MalfunctionFeb 26, 2025Low Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED RESULTS WERE OBTAINED FROM VITROS CALCIUM (CA) SLIDE LOT 0359-0685-5671 FROM A SINGLE LEVEL OF NON-THERMOFISHER MAS OMNICORE (MAS) CONTROLS, LOT OCR2608 TESTED ON A VITROS 5600 INTEGRATED SYSTEM. MAS LEVEL 3 VITROS CA RESULTS OF 9.49, 9.44, 9.44, 9.69, 9.39 AND 6.14 MG/DL VS. THE EXPECTED RESULT OF 12.20 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 LOWER-THAN-EXPECTED VITROS CA RESULTS WERE OBTAINED FROM A NON-PATIENT QUALITY CONTROL FLUID. THERE WAS NO ALLEGATION OF 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 21468290 ↗