VITROS 6801925Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10758750001682), received between Jan 4, 2023 and Dec 16, 2025 — classified as 15 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (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. Nov 27, 2023Open, Classified

   Affected lots may experience increased calibration failures or an increase in falsely elevated results.

   Z-0772-2024 · Root cause: Nonconforming Material/Component · FDA record ↗

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 16, 2025False Positive Result; False Positive Result

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT REPRODUCIBLE, DISCORDANT POSITIVE VITROS AHBS RESULTS WERE OBTAINED FROM A SINGLE PATIENT SAMPLE TESTED ON TWO DIFFERENT VITROS XT7600 INTEGRATED SYSTEMS USING VITROS AHBS REAGENT LOT 5280. THE VITROS AHBS POSITIVE RESULTS GENERATED FROM REAGENT LOT 5280 WERE DISCORDANT WHEN COMPARED TO ANTI-HBS NEGATIVE RESULTS OBTAINED FROM THE SAME SAMPLE USING TWO DIFFERENT NON-VITROS METHODS. VITROS AHBS POSITIVE RESULTS OF 46 AND 22 MIU/ML (>12 IS ANTIBODY POS) VS. THE EXPECTED RESULT OF NEGATIVE. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE DISCORDANT POSITIVE VITROS AHBS RESULTS WERE 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 NUMBERS (B)(4), AND REPORTABILITY ASSESSMENT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23821008 ↗
• MalfunctionJul 17, 2025False Negative Result; False Negative Result

  AN ORTHO CLINICAL DIAGNOSTICS (ORTHO) QUALITY ENGINEER (QE) REPORTED FALSE REACTIVE ANTI-HBS (AHBS) RESULTS WHEN AN IN-HOUSE QUALITY CONTROL (QC) WAS TESTED USING VITROS HEPATITIS B SURFACE ANTIGEN (AHBS) LOT 5215 ON TWO VITROS ECI IMMUNODIAGNOSTIC SYSTEMS AS PART OF STABILITY TESTING. IN-HOUSE CONTROL C-B11 RESULTS OF 16.0 AND 12.1 MIU/ML (REACTIVE) VERSUS THE EXPECTED RESULT OF 5.7 TO 10.7 MIU/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 FALSE REACTIVE VITROS AHBS RESULTS WERE OBTAINED FROM A NON-PATIENT FLUID AS PART OF INTERNAL STABILITY TESTING AT ORTHO PENCOED. THERE HAS BEEN 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 22529868 ↗
• MalfunctionJan 9, 2025False Positive Result; False Positive Result

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTIONS CENTER (TSC) TO REPORT REPRODUCIBLE DISCORDANT POSITIVE RESULTS OBTAINED FROM A PATIENT SAMPLE PROCESSED USING VITROS ANTI-HBS (AHBS) REAGENT LOT 5200 ON TWO VITROS XT7600 INTEGRATED SYSTEMS WHEN COMPARED TO ANTI-HBS NEGATIVE RESULTS OBTAINED FROM TWO NON-VITROS SYSTEMS AS WELL AS ALTERNATE VITROS ANTI-HBS REAGENT LOTS. VITROS ANTI-HBS RESULTS 30.9, 28.8 MIU/ML (>12 IS ANTIBODY POS) VS. THE EXPECTED RESULT OF NEGATIVE. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE DISCORDANT POSITIVE VITROS AHBS RESULTS WERE NOT REPORTED FROM THE LABORATORY AND 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 REPORTABILITY ASSESSMENT 608544.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21114711 ↗
• MalfunctionJan 9, 2025False Positive Result; False Positive Result

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTIONS CENTER (TSC) TO REPORT REPRODUCIBLE DISCORDANT POSITIVE RESULTS OBTAINED FROM A PATIENT SAMPLE PROCESSED USING VITROS ANTI-HBS (AHBS) REAGENT LOT 5200 ON TWO VITROS XT7600 INTEGRATED SYSTEMS WHEN COMPARED TO ANTI-HBS NEGATIVE RESULTS OBTAINED FROM TWO NON-VITROS SYSTEMS AS WELL AS ALTERNATE VITROS ANTI-HBS REAGENT LOTS. VITROS ANTI-HBS RESULTS 30.9, 28.8 MIU/ML (>12 IS ANTIBODY POS) VS. THE EXPECTED RESULT OF NEGATIVE. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE DISCORDANT POSITIVE VITROS AHBS RESULTS WERE NOT REPORTED FROM THE LABORATORY AND 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) AND REPORTABILITY ASSESSMENT 608544.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21112142 ↗
• MalfunctionJun 11, 2024False Positive Result; Non Reproducible Results; False Positive Result; Non Reproducible Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A NON-REPRODUCIBLE, DISCORDANT POSITIVE VITROS ANTI-HBS (AHBS) RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE TESTED ON A VITROS 5600 INTEGRATED SYSTEM. THE VITROS AHBS POSITIVE RESULT GENERATED FROM REAGENT LOT 9030 WAS DISCORDANT WHEN COMPARED TO MULTIPLE VITROS AHBS NEGATIVE RESULTS OBTAINED FROM THE SAME SAMPLE USING AN ALTERNATE VITROS AHBS REAGENT, LOT 9050. VITROS AHBS RESULT OF POSITIVE (52.0 MIU/ML) VS. THE EXPECTED RESULT OF NEGATIVE BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE DISCORDANT POSITIVE VITROS AHBS RESULT WAS OBTAINED FOR PRE-EMPLOYMENT SCREEN OF A NEW HIRE. THE DISCORDANT POSITIVE VITROS AHBS RESULT WAS REMOVED FROM THE EMPLOYEES RECORDS AND A AHBS NEGATIVE RESULT WAS DOCUMENTED. 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 19510592 ↗
• MalfunctionMay 17, 2024False Positive Result; False Positive Result

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT DISCORDANT, POSITIVE VITROS ANTI-HBS (AHBS) RESULTS WERE OBTAINED FROM A SINGLE PATIENT SAMPLE WHEN TESTED USING TWO DIFFERENT LOTS OF VITROS AHBS REAGENT ON TWO DIFFERENT VITROS 3600 IMMUNODIAGNOSTIC SYSTEMS. THE VITROS RESULTS WERE CONSIDERED DISCORDANT WHEN COMPARED TO A NON-VITROS ABBOTT AHBS NEGATIVE RESULT FOR THE SAME PATIENT SAMPLE. VITROS AHBS REGENT LOT 5120 TESTED ON J36000868 PATIENT 1 RESULTS OF POSITIVE (25.7 AND 23.5 MIU/ML) VS EXPECTED RESULTS OF NEGATIVE. VITROS AHBS REGENT LOT 5130 TESTED ON J36000869 PATIENT 1 RESULT OF POSITIVE (19.7 MIU/ML) VS EXPECTED RESULTS OF NEGATIVE BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE VITROS AHBS RESULTS WERE REPORTED FROM THE LABORATORY. HOWEVER, NO TREATMENT WAS INITIATED, ALTERED, OR STOPPED BASED ON THE REPORTED RESULTS. ORTHO HAS NOT BEEN MADE AWARE OF ANY ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER TWO OF TWO 3500A FORMS FILED FOR THIS EVENT, AS TWO DEVICES WERE AFFECTED. THIS REPORT CORRESPONDS TO ORTH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19341303 ↗
• MalfunctionMar 29, 2024High Test Results; High Test Results

  AN ORTHO CLINICAL DIAGNOSTICS (ORTHO) QUALITY ENGINEER (QE) REPORTED A HIGHER THAN EXPECTED VITROS AHBS RESULT WAS OBTAINED WHEN AN INHOUSE CONTROL FLUID WAS PROCESSED USING VITROS AHBS LOT 8955 IN COMBINATION WITH A VITROS ECI IMMUNODIAGNOSTIC SYSTEM AS PART OF AS PART OF INTERNAL POST-EXPIRY STABILITY TESTING AT ORTHO PENCOED. IN-HOUSE CONTROL C-A11 RESULT OF 17.0 MIU/ML (POSITIVE) VERSUS THE EXPECTED RESULT OF ?2 MIU/ML (NEGATIVE) 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 AHBS RESULT WAS OBTAINED FROM A NON-PATIENT FLUID AS PART OF INTERNAL STABILITY TESTING AT ORTHO. 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) NONCONFORMANCE NUMBER (B)(4) AND REPORTABILITY ASSESSMENT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19005510 ↗
• MalfunctionJan 17, 2024False Positive Result; False Positive Result

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT DISCORDANT, POSITIVE VITROS ANTI-HBS (AHBS) RESULTS WERE OBTAINED FROM A SINGLE PATIENT SAMPLE WHEN TESTED USING TWO DIFFERENT LOTS OF VITROS AHBS REAGENT ON TWO DIFFERENT VITROS 3600 IMMUNODIAGNOSTIC SYSTEMS. THE VITROS RESULTS WERE CONSIDERED DISCORDANT WHEN COMPARED TO A NON-VITROS ABBOTT AHBS NEGATIVE RESULT FOR THE SAME PATIENT SAMPLE. VITROS AHBS REGENT LOT 5120 TESTED ON (B)(6) PATIENT 1 RESULTS OF POSITIVE (25.7 AND 23.5 MIU/ML) VS EXPECTED RESULTS OF NEGATIVE. VITROS AHBS REGENT LOT 5130 TESTED ON (B)(6) PATIENT 1 RESULT OF POSITIVE (19.7 MIU/ML) VS EXPECTED RESULTS OF NEGATIVE BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE VITROS AHBS RESULTS WERE REPORTED FROM THE LABORATORY. HOWEVER, NO TREATMENT WAS INITIATED, ALTERED, OR STOPPED BASED ON THE REPORTED RESULTS. ORTHO HAS NOT BEEN MADE AWARE OF ANY ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER ONE OF TWO 3500A FORMS FILED FOR THIS EVENT, AS TWO DEVICES WERE AFFECTED. THIS REPORT CORRESPONDS TO ORTHO CLIN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18524845 ↗
• MalfunctionDec 1, 2023False Positive Result; False Positive Result

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT FALSE POSITIVE ANTI-HBS (AHBS) RESULTS WERE OBTAINED FROM TWO DIFFERENT PATIENT SAMPLES AND A NON-VITROS KANGCHESI TAN QC NEGATIVE QUALITY CONTROL FLUID USING THE VITROS ANTI-HBS REAGENT LOT 5070 ON A VITROS 3600 IMMUNODIAGNOSTIC SYSTEM. PATIENT 2 RESULT OF 88.0 MIU/ML (POSITIVE) VS EXPECTED RESULT OF 0.00 MIU/ML (NEGATIVE). PATIENT 8 RESULT OF 82.3 MIU/ML (POSITIVE) VS EXPECTED RESULT OF 0.00 MIU/ML (NEGATIVE). KANGCHESI TAN QC RESULTS OF 136.7 AND 140.0 MIU/ML (POSITIVE) VS THE EXPECTED RESULT OF <8.00 (NEGATIVE) MIU/ML BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE HIGHER THAN EXPECTED, FALSE POSITIVE VITROS ANTI-HBS RESULTS WERE NOT 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) (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18245418 ↗
• MalfunctionNov 16, 2023False Positive Result; False Positive Result

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT FALSE POSITIVE VITROS ANTI-HBS (AHBS) RESULTS WERE OBTAINED FROM FIFTEEN (15) DIFFERENT PATIENT SAMPLES AND DISCORDANT FALSE POSITIVE, HIGHER THAN EXPECTED QUALITY CONTROL RESULTS WERE OBTAINED WHEN USING VITROS AHBS REAGENT LOT 5070 ON A VITROS 3600 IMMUNODIAGNOSTIC SYSTEM. PATIENT 1, RESULT OF 86.8 MIU/ML (POSITIVE) VS EXPECTED RESULTS OF 1.18 MIU/ML (NEGATIVE). PATIENT 2, RESULT OF 63.2 MIU/ML (POSITIVE) VS EXPECTED RESULTS OF 0.00 MIU/ML (NEGATIVE). PATIENT 3, RESULT OF 64 MIU/ML (POSITIVE) VS EXPECTED RESULTS OF 0.14 MIU/ML (NEGATIVE). PATIENT 4, RESULT OF 83.8 MIU/ML (POSITIVE) VS EXPECTED RESULTS OF 0.01 MIU/ML (NEGATIVE). PATIENT 5, RESULT OF 90.8 MIU/ML (POSITIVE) VS EXPECTED RESULTS OF 0.00 MIU/ML (NEGATIVE). PATIENT 6, RESULT OF 86.5 MIU/ML (POSITIVE) VS EXPECTED RESULTS OF 0.00 MIU/ML (NEGATIVE). PATIENT 7, RESULT OF 92.5 MIU/ML (POSITIVE) VS EXPECTED RESULTS OF 0.00 MIU/ML (NEGATIVE). PATIENT 8, RESULT OF 65.8 MIU/ML (POSITIVE) VS EXPECTED RESULTS OF 0.00 MIU/ML (NEGATIVE). PATIENT 9, RESULT OF 72.7 MIU/ML (POSITIVE) VS EXPECTED RESULTS OF 0.00 MIU/ML (NEGATIVE). PATIE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18149816 ↗
• MalfunctionOct 25, 2023False Positive Result; False Positive Result

  A ORTHO CLINICAL DIAGNOSTICS (ORTHO) QUALITY ENGINEER REPORTED INCREASED QUALITY CONTROL CALIBRATION FAILURE RESULTS FOR VITROS ANTI-HBS (AHBS) REAGENT LOT 8940. VITROS ANTI-HBS KIT LOT 8940 WAS TESTED AND FOUND THE REAGENT LOT HAD GENERATED ONE FALSE POSITIVE ANTI-HBS RESULT FOR SAMPLE ((B)(6)) CONSIDERED TO BE TRULY ANTI-HBS NEGATIVE VITROS ANTI-HBS LOT 8940 SAMPLE (B)(6) RESULT 13.5 MIU/ML (REACTIVE / POSITIVE) VS. EXPECTED RESULT OF NEGATIVE. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. THE UNEXPECTED POSITIVE AHBS RESULT OCCURRED ON A KNOWN NEGATIVE PANEL SAMPLE USED FOR INTERNAL TESTING AND THERE IS NO REPORT OF AFFECTED PATIENT SAMPLES. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) NONCONFORMANCE NUMBER (B)(4) AND REPORTABILITY ASSESSMENT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18003116 ↗
• MalfunctionJun 22, 2023High Test Results; High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED ANTI-HBS (AHBS) RESULTS WERE OBTAINED WHEN TESTING A NON-VITROS (BIORAD) NEGATIVE QUALITY CONTROL (QC) FLUID USING A VITROS AHBS REAGENT ON A VITROS XT 7600 IMMUNODIAGNOSTIC SYSTEM. VITROS AHBS RESULTS OF 12.6784, 12.8649 AND 14.2543 MIU/ML VERSUS EXPECTED RESULTS OF NEGATIVE. 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 AHB RESULTS WERE OBTAINED FROM NON-PATIENT FLUIDS. ORTHO HAS NOT BEEN MADE AWARE OF ANY ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENTS. 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 ASSESSMENT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17184191 ↗
• MalfunctionJun 22, 2023High Test Results; High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED ANTI-HBS (AHBS) RESULTS WERE OBTAINED WHEN TESTING A NON-VITROS (BIORAD) NEGATIVE QUALITY CONTROL (QC) FLUID USING A VITROS AHBS REAGENT ON A VITROS XT 7600 IMMUNODIAGNOSTIC SYSTEM. VITROS AHBS RESULTS OF 12.6784, 12.8649 AND 14.2543 MIU/ML VERSUS EXPECTED RESULTS OF NEGATIVE. 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 AHB RESULTS WERE OBTAINED FROM NON-PATIENT FLUIDS. ORTHO HAS NOT BEEN MADE AWARE OF ANY ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENTS. 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 ASSESSMENT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17184130 ↗
• MalfunctionJun 22, 2023High Test Results; High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED ANTI-HBS (AHBS) RESULTS WERE OBTAINED WHEN TESTING A NON-VITROS (BIORAD) NEGATIVE QUALITY CONTROL (QC) FLUID USING A VITROS AHBS REAGENT ON A VITROS XT 7600 IMMUNODIAGNOSTIC SYSTEM. VITROS AHBS RESULTS OF 12.6784, 12.8649 AND 14.2543 MIU/ML VERSUS EXPECTED RESULTS OF NEGATIVE. 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 AHB RESULTS WERE OBTAINED FROM NON-PATIENT FLUIDS. ORTHO HAS NOT BEEN MADE AWARE OF ANY ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENTS. 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 ASSESSMENT 602284.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17184026 ↗
• MalfunctionJan 4, 2023False Negative Result; False Positive Result; False Negative Result; False Positive Result

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT DISCORDANT, NON-REACTIVE VITROS ANTI-HBC (AHBC) RESULTS AND DISCORDANT, POSITIVE VITROS ANTI-HBS (AHBS) SAMPLES FROM ONE PATIENT WERE TESTED USING VITROS AHBC LOT 2680 AND VITROS AHBS LOT 3990 ON A VITROS 5600 IMMUNODIAGNOSTIC SYSTEM. THE VITROS RESULTS WERE CONSIDERED DISCORDANT WHEN COMPARED TO RESULTS FROM A NON-VITROS (ABBOTT) METHOD. PATIENT 1, VITROS AHBS RESULTS OF 40.76 AND 48.27 MIU/L (POSITIVE) VERSUS THE EXPECTED RESULT OF NEGATIVE PATIENT 1, VITROS AHBC RESULT OF 1.98 AND 1.87 S/C (NON-REACTIVE) VERSUS THE EXPECTED RESULT OF REACTIVE THE DISCORDANT VITROS AHBC AND VITROS AHBS RESULTS WERE NOT REPORTED FROM THE LABORATORY. ORTHO HAS NOT BEEN MADE AWARE OF ANY 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. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER (B)(4) AND REPORTABILITY ASSESSMENT 600429.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16097132 ↗