VITROS 6842905Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10758750030729), received between Dec 15, 2025 and Sep 29, 2026 — classified as 21 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (15 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. Apr 17, 2023Open, Classified

   Potential for both unexpected positive and negative HbA1c results, may result in misdiagnosis

   Z-1628-2023 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026High Test Results

  A customer contacted the Ortho Clinical Diagnostics (Ortho) Technical Solution Center (TSC) to report higher than expected HbA1c results were obtained from a non-VITROS BioRad quality control processed using VITROS Chemistry Products HbA1c Reagent Lot 2539-51-3990 on a VITROS XT 7600 Integrated System. BioRad Lot 89280 Level 2 results of 10.2, 10.4, 10.4 and 10.5 %A1c vs an expected result of 8.6 %A1c 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 results were obtained from a control fluid and were not reported out of the laboratory. 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 report corresponds to Ortho Clinical Diagnostics Inc (Ortho) complaint number 101168810 and Reportability Assessment 615838.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50937674 ↗
• MalfunctionSep 29, 2026High Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50937661 ↗
• MalfunctionSep 2, 2026Low Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50569483 ↗
• MalfunctionSep 2, 2026Low Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50569445 ↗
• MalfunctionJun 23, 2026High Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER AND HIGHER THAN EXPECTED VITROS CHEMISTRY PRODUCTS HBA1C REAGENT LOT 2539-48-3598 RESULTS OBTAINED FROM TWO DIFFERENT LOTS OF VITROS %A1C PERFORMANCE VERIFIER (PV) FLUIDS ON A VITROS 5600 INTEGRATED SYSTEM. VITROS %A1C PV II, LOT E3136 VITROS HBA1C RESULTS OF 8.19, 12.17, 12.13, 7.90, 7.94, AND 8.09 % NGSP VS. THE RANGE OF MEANS MIDPOINT OF 9.52 % NGSP. VITROS %A1C PV II, LOT X2393 VITROS HBA1C RESULTS OF 7.78 AND 8.06 % NGSP VS. THE RANGE OF MEANS MIDPOINT OF 9.70 % NGSP. 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 AND HIGHER THAN EXPECTED VITROS HBA1C RESULTS WERE OBTAINED FROM A QUALITY CONTROL FLUID. THE CUSTOMER CONFIRMED THAT THERE HAS BEEN NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER FOUR OF FOUR 3500A FORMS BEING SUBMITTED FOR THIS EVENT AS FOUR DEVICES WERE INVOLVED. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER (B)(4) AND REPORTABILITY ASSESSMENT 614878.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25596636 ↗
• MalfunctionJun 23, 2026High Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER AND HIGHER THAN EXPECTED VITROS CHEMISTRY PRODUCTS HBA1C REAGENT LOT 2539-48-3598 RESULTS OBTAINED FROM TWO DIFFERENT LOTS OF VITROS %A1C PERFORMANCE VERIFIER (PV) FLUIDS ON A VITROS 5600 INTEGRATED SYSTEM. VITROS %A1C PV II, LOT E3136 VITROS HBA1C RESULTS OF 8.19, 12.17, 12.13, 7.90, 7.94, AND 8.09 % NGSP VS. THE RANGE OF MEANS MIDPOINT OF 9.52 % NGSP. VITROS %A1C PV II, LOT X2393 VITROS HBA1C RESULTS OF 7.78 AND 8.06 % NGSP VS. THE RANGE OF MEANS MIDPOINT OF 9.70 % NGSP. 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 AND HIGHER THAN EXPECTED VITROS HBA1C RESULTS WERE OBTAINED FROM A QUALITY CONTROL FLUID. THE CUSTOMER CONFIRMED THAT THERE HAS BEEN NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER TWO OF FOUR 3500A FORMS BEING SUBMITTED FOR THIS EVENT AS FOUR 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 25596607 ↗
• MalfunctionMay 11, 2026Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED RESULTS OBTAINED FROM A NON-VITROS BIORAD (LOT 89290) %A1C LEVEL 3 QUALITY CONTROL FLUID TESTED USING VITROS HBA1C REAGENT ON A VITROS 5600 INTEGRATED SYSTEM. BIORAD LEVEL 3 RESULTS OF 4.48, 4.59, 4.56, 4.55, 4.58 %A1C VS THE EXPECTED RESULT OF 8.52 %A1C (BASELINE MEAN) 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 HBA1C RESULTS WERE OBTAINED FROM A QUALITY CONTROL FLUID. THE CUSTOMER DID NOT RUN VITROS HBA1C PATIENT TESTING AS THE QC WAS UNACCEPTABLE. 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 25137264 ↗
• MalfunctionApr 8, 2026Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED RESULTS OBTAINED FROM A BIORAD (LOT 1006900) %A1C LEVEL 3 QUALITY CONTROL FLUID TESTED USING VITROS HBA1C REAGENT ON A VITROS 5600 INTEGRATED SYSTEM. BIORAD LEVEL 3 = 9.25859, 10.3176, 10.3872 VERSUS PEER MEAN = 11.78 (NGSP UNITS = %) 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 HBA1C RESULTS WERE OBTAINED FROM A QUALITY CONTROL FLUID. THE CUSTOMER DID NOT RUN VITROS HBA1C PATIENT TESTING AS THE QC WAS UNACCEPTABLE. 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 613994.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24817911 ↗
• MalfunctionApr 3, 2026Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED VITROS HBA1C REAGENT LOT 2539-44-3184 RESULTS WERE OBTAINED FROM TWO DIFFERENT LEVELS OF VITROS %A1C PERFORMANCE VERIFIER (PV) FLUIDS ON A VITROS 5600 INTEGRATED SYSTEM. VITROS %A1C PV I, LOT W2392 VITROS HBA1C RESULTS OF 4.06 AND 4.09 % NGSP VS. THE RANGE OF MEANS MIDPOINT OF 5.73 % NGSP VITROS %A1C PV II, LOT X2393 VITROS HBA1C RESULTS OF 6.30, 7.55, 7.51 AND 7.68 % NGSP VS. THE RANGE OF MEANS MIDPOINT OF 9.30 % NGSP 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 HBA1C RESULTS WERE OBTAINED FROM NON-PATIENT QUALITY CONTROL FLUIDS. 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 24777694 ↗
• MalfunctionMar 9, 2026High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED VITROS %A1C RESULTS WERE OBTAINED FROM A SINGLE SAMPLE PROCESSED USING VITROS CHEMISTRY PRODUCTS HBA1C REAGENT LOT 1539-45-3118 ON A VITROS 5600 INTEGRATED SYSTEM. THE RESULTS WERE HIGHER THAN EXPECTED WHEN COMPARED TO THE RESULT OBTAINED ON FROM A FINGER CAPILLARY PUNCTURE SAMPLE USING A SIEMENS DCA VANTAGE POINT OF CARE (POC) TEST SYSTEM. VITROS %A1C SAMPLE RESULTS OF 6.7% AND 6.9% VS THE EXPECTED RESULT OF 5.5% 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 HBA1C RESULTS WERE OBTAINED FROM A SAMPLE OBTAINED FROM THE VITROS OPERATOR AT THE CUSTOMER SITE FOR TROUBLESHOOTING PURPOSES ONLY AND WAS NOT REPORTED OUTSIDE OF THE LABORATORY. 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) AND R

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24552180 ↗
• MalfunctionMar 9, 2026High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED VITROS %A1C RESULTS WERE OBTAINED FROM A SINGLE SAMPLE PROCESSED USING VITROS CHEMISTRY PRODUCTS HBA1C REAGENT LOT: 1539-45-3118 ON A VITROS 5600 INTEGRATED SYSTEM. THE RESULTS WERE HIGHER THAN EXPECTED WHEN COMPARED TO THE RESULT OBTAINED ON FROM A FINGER CAPILLARY PUNCTURE SAMPLE USING A SIEMENS DCA VANTAGE POINT OF CARE (POC) TEST SYSTEM. VITROS %A1C SAMPLE RESULTS OF 6.7% AND 6.9% VS THE EXPECTED RESULT OF 5.5% 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 HBA1C RESULTS WERE OBTAINED FROM A SAMPLE OBTAINED FROM THE VITROS OPERATOR AT THE CUSTOMER SITE FOR TROUBLESHOOTING PURPOSES ONLY AND WAS NOT REPORTED OUTSIDE OF THE LABORATORY. 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).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24552175 ↗
• MalfunctionFeb 26, 2026Low Test Results

  AN ORTHO CLINICAL DIAGNOSTICS (ORTHO) QUALITY ENGINEER CONTACTED THE ORTHO COMPLAINT HANDLING UNIT (CHU) TO REPORT LOWER THAN EXPECTED RESULTS OBTAINED FROM A VITROS %A1C PERFORMANCE VERIFIER (PV) FLUID TESTED USING VITROS HBA1C REAGENT ON TWO VITROS 4600 CHEMISTRY SYSTEMS. THE VITROS HBA1C RESULTS WERE LOW WHEN COMPARED THE VITROS PVII CENTER OF THE RANGE OF MEANS (CROM). VITROS S/N (B)(6), PVII N1620 RESULTS OF 8.357, 8.386, 8.257, 8.305 VERSUS THE CROM RESULT OF 10.42 VITROS S/N (B)(6), PVII T2023 RESULTS OF 9.257, 9.247, 9.170 VERSUS THE CROM RESULT OF 10.43 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 HBA1C RESULTS WERE TESTED AS PART OF INTERNAL TESTING USING VITROS PV FLUIDS AND NO PATIENT TESTING WAS PERFORMED. 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. NONCONFORMANCE NC0613539/RA613574.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24455353 ↗
• MalfunctionFeb 26, 2026Low Test Results

  AN ORTHO CLINICAL DIAGNOSTICS (ORTHO) QUALITY ENGINEER CONTACTED THE ORTHO COMPLAINT HANDLING UNIT (CHU) TO REPORT LOWER THAN EXPECTED RESULTS OBTAINED FROM A VITROS %A1C PERFORMANCE VERIFIER (PV) FLUID TESTED USING VITROS HBA1C REAGENT ON TWO VITROS 4600 CHEMISTRY SYSTEMS. THE VITROS HBA1C RESULTS WERE LOW WHEN COMPARED THE VITROS PVII CENTER OF THE RANGE OF MEANS (CROM). VITROS S/N (B)(6) PVII N1620 RESULTS OF 8.357, 8.386, 8.257, 8.305 VERSUS THE CROM RESULT OF 10.42 VITROS S/N (B)(6) PVII T2023 RESULTS OF 9.257, 9.247, 9.170 VERSUS THE CROM RESULT OF 10.43 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 HBA1C RESULTS WERE TESTED AS PART OF INTERNAL TESTING USING VITROS PV FLUIDS AND NO PATIENT TESTING WAS PERFORMED. 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. NONCONFORMANCE NC0613539 / RA613574.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24455346 ↗
• MalfunctionFeb 6, 2026High Test Results; Non Reproducible Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A NON-REPRODUCIBLE, HIGHER THAN EXPECTED VITROS HBA1C RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE USING VITROS CHEMISTRY PRODUCTS HBA1C REAGENT LOT 1539-42-2750 ON A VITROS XT7600 INTEGRATED SYSTEM. PATIENT SAMPLE VITROS HBA1C RESULT OF 11.13 % NGSP VS. THE EXPECTED RESULT OF 7.02 % NGSP 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 HBA1C RESULT WAS 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 24280823 ↗
• MalfunctionJan 13, 2026High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED HBA1C RESULTS WERE OBTAINED FROM NON-VITROS MAS QUALITY CONTROLS AS WELL AS SAMPLES FROM MULTIPLE DIFFERENT PATIENTS PROCESSED USING VITROS CHEMISTRY PRODUCTS HBA1C REAGENT LOT 1539-45-3329 ON A VITROS 5600 INTEGRATED SYSTEM. MAS LOT DBCL2605 LEVEL 1 RESULTS OF 6.96, 6.99, AND 7.12 %A1C VS AN EXPECTED RESULT OF 5.21 %A1C MAS LOT DBCL2605 LEVEL 2 RESULTS OF 11.88, 11.89 AND 12.30 %A1C VS AN EXPECTED RESULT OF 8.04 %A1C PATIENT 1 RESULT OF 11.6 %A1C VS AN EXPECTED RESULT OF 6.6 %A1C PATIENT 2 RESULT OF 8.3 %A1C VS AN EXPECTED RESULT OF 6.7 %A1C PATIENT 3 RESULT OF 9.2 %A1C VS AN EXPECTED RESULT OF 6.4 %A1C PATIENT 4 RESULT OF 7.3 %A1C VS AN EXPECTED RESULT OF 5.5 %A1C PATIENT 5 RESULT OF 6.4 %A1C VS AN EXPECTED RESULT OF 4.8 %A1C PATIENT 6 RESULT OF 7.0 %A1C VS AN EXPECTED RESULT OF 5.0 %A1C PATIENT 7 RESULT OF 6.8 %A1C VS AN EXPECTED RESULT OF 4.8 %A1C BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE HIGHER-THAN-EXPECTED PATIENT SAMPLE RESULTS WERE REPORTED OUT OF THE LABORATO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24052991 ↗
• MalfunctionDec 15, 2025High Test Results; Low Test Results; High Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER AND HIGHER THAN EXPECTED VITROS HBA1C REAGENT LOT: 1519-46-3073 RESULTS WERE OBTAINED FROM TWO DIFFERENT LEVELS OF NON-VITROS BIORAD LIQUICHEK DIABETES LOT: 89290 CONTROLS ON A VITROS XT 7600 SYSTEM. BIORAD LEVEL 1 VITROS HBA1C RESULTS OF 6.30, 6.35 AND 6.32 % NGSP VS. THE BASELINE MEAN OF 5.24 % NGSP. BIORAD LEVEL 2 VITROS HBA1C RESULTS OF 7.30, 9.95, 10.02, 9.95, 7.22, 7.20, 7.10, 7.10, 7.10, 7.02, 10.44 AND 10,51 % NGSP VS. THE BASELINE MEAN OF 8.39 % NGSP. 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 HBA1C RESULTS WERE OBTAINED FROM NON-PATIENT QUALITY CONTROL FLUIDS. 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).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23809970 ↗
• MalfunctionDec 15, 2025High Test Results; Low Test Results; High Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER AND HIGHER THAN EXPECTED VITROS HBA1C REAGENT LOT: 1519-46-3073 RESULTS WERE OBTAINED FROM TWO DIFFERENT LEVELS OF NON-VITROS BIORAD LIQUICHEK DIABETES LOT: 89290 CONTROLS ON A VITROS XT 7600 SYSTEM. BIORAD LEVEL 1 VITROS HBA1C RESULTS OF 6.30, 6.35 AND 6.32 % NGSP VS. THE BASELINE MEAN OF 5.24 % NGSP. BIORAD LEVEL 2 VITROS HBA1C RESULTS OF 7.30, 9.95, 10.02, 9.95, 7.22, 7.20, 7.10, 7.10, 7.10, 7.02, 10.44 AND 10,51 % NGSP VS. THE BASELINE MEAN OF 8.39 % NGSP. 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 HBA1C RESULTS WERE OBTAINED FROM NON-PATIENT QUALITY CONTROL FLUIDS. 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).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23809967 ↗
• MalfunctionDec 15, 2025High Test Results; Low Test Results; High Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER AND HIGHER THAN EXPECTED VITROS HBA1C REAGENT LOT: 1519-46-3073 RESULTS WERE OBTAINED FROM TWO DIFFERENT LEVELS OF NON-VITROS BIORAD LIQUICHEK DIABETES LOT: 89290 CONTROLS ON A VITROS XT 7600 SYSTEM. BIORAD LEVEL 1 VITROS HBA1C RESULTS OF 6.30, 6.35 AND 6.32 % NGSP VS. THE BASELINE MEAN OF 5.24 % NGSP. BIORAD LEVEL 2 VITROS HBA1C RESULTS OF 7.30, 9.95, 10.02, 9.95, 7.22, 7.20, 7.10, 7.10, 7.10, 7.02, 10.44 AND 10,51 % NGSP VS. THE BASELINE MEAN OF 8.39 % NGSP. 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 HBA1C RESULTS WERE OBTAINED FROM NON-PATIENT QUALITY CONTROL FLUIDS. 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).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23809922 ↗
• MalfunctionDec 15, 2025High Test Results; Low Test Results; High Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER AND HIGHER THAN EXPECTED VITROS HBA1C REAGENT LOT 1519-46-3073 RESULTS WERE OBTAINED FROM TWO DIFFERENT LEVELS OF NON-VITROS BIORAD LIQUICHEK DIABETES LOT 89290 CONTROLS ON A VITROS XT 7600 SYSTEM. BIORAD LEVEL 1 VITROS HBA1C RESULTS OF 6.30, 6.35 AND 6.32 % NGSP VS. THE BASELINE MEAN OF 5.24 % NGSP. BIORAD LEVEL 2 VITROS HBA1C RESULTS OF 7.30, 9.95, 10.02, 9.95, 7.22, 7.20, 7.10, 7.10, 7.10, 7.02, 10.44 AND 10,51 % NGSP VS. THE BASELINE MEAN OF 8.39 % NGSP. 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 HBA1C RESULTS WERE OBTAINED FROM NON-PATIENT QUALITY CONTROL FLUIDS. 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 23809912 ↗
• MalfunctionDec 15, 2025High Test Results; Low Test Results; High Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER AND HIGHER THAN EXPECTED VITROS HBA1C REAGENT LOT 1519-46-3073 RESULTS WERE OBTAINED FROM TWO DIFFERENT LEVELS OF NON-VITROS BIORAD LIQUICHEK DIABETES LOT 89290 CONTROLS ON A VITROS XT 7600 SYSTEM. BIORAD LEVEL 1 VITROS HBA1C RESULTS OF 6.30, 6.35 AND 6.32 % NGSP VS. THE BASELINE MEAN OF 5.24 % NGSP. BIORAD LEVEL 2 VITROS HBA1C RESULTS OF 7.30, 9.95, 10.02, 9.95, 7.22, 7.20, 7.10, 7.10, 7.10, 7.02, 10.44 AND 10,51 % NGSP VS. THE BASELINE MEAN OF 8.39 % NGSP. 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 HBA1C RESULTS WERE OBTAINED FROM NON-PATIENT QUALITY CONTROL FLUIDS. 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 23809898 ↗
• MalfunctionDec 15, 2025High Test Results; Low Test Results; High Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER AND HIGHER THAN EXPECTED VITROS HBA1C REAGENT LOT 1519-46-3073 RESULTS WERE OBTAINED FROM TWO DIFFERENT LEVELS OF NON-VITROS BIORAD LIQUICHEK DIABETES LOT 89290 CONTROLS ON A VITROS XT 7600 SYSTEM. BIORAD LEVEL 1 VITROS HBA1C RESULTS OF 6.30, 6.35 AND 6.32 % NGSP VS. THE BASELINE MEAN OF 5.24 % NGSP. BIORAD LEVEL 2 VITROS HBA1C RESULTS OF 7.30, 9.95, 10.02, 9.95, 7.22, 7.20, 7.10, 7.10, 7.10, 7.02, 10.44 AND 10,51 % NGSP VS. THE BASELINE MEAN OF 8.39 % NGSP. 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 HBA1C RESULTS WERE OBTAINED FROM NON-PATIENT QUALITY CONTROL FLUIDS. 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 23809857 ↗