VITROS 6801322Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10758750001064), received between Mar 24, 2023 and Jul 14, 2025 — classified as 8 malfunctions.

The most frequently reported specific device problem is “False Negative Result” (8 reports).

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.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 14, 2025False Negative Result; Incorrect Measurement; False Negative Result; Incorrect Measurement

  A DISTRIBUTOR CONTACTED ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTIONS CENTRE (TSC) ON BEHALF OF A CUSTOMER TO REPORT A DISCORDANT FALSE NEGATIVE VITROS HBSAG ES RESULT WAS OBTAINED, WHEN TESTED USING NON-VITROS EXTERNAL QUALITY ASSESSMENT (EQA) PROFICIENCY FLUIDS USING VITROS HEPATITIS B SURFACE ANTIGEN (HBSAG ES) REAGENT LOT 2170 ON A VITROS 3600 IMMUNODIAGNOSTIC SYSTEM. EQA SAMPLE S001 VITROS HBSAG ES RESULT OF 0.70 S/C (NON-REACTIVE) VS AN EXPECTED RESULT OF REACTIVE. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. THE DISCORDANT FALSE NEGATIVE VITROS HBSAG ES RESULT WAS GENERATED WHEN A CUSTOMER WAS PROCESSING NON-PATIENT FLUIDS. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THE EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER (B)(4) AND REPORTABILITY ASSESSMENT 611362.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22494675 ↗
• MalfunctionDec 2, 2024False Negative Result; False Negative Result

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT DISCORDANT, NON-REACTIVE HBSAG RESULTS WERE OBTAINED WHEN NON-VITROS EXTERNAL QUALITY ASSESSMENT (EQA) PROFICIENCY SAMPLES WERE TESTED USING VITROS HBSAG ES LOT 3530 AND LOT 3551 ON A VITROS 3600 IMMUNODIAGNOSTIC SYSTEM. THE RESULTS WERE DISCORDANT WHEN COMPARED TO HBSAG RESULTS FROM NON-VITROS (ABBOTT AND SYSMEX) METHODS. VITROS HBSAG LOT 3530 RESULTS: SAMPLE (B)(6), RESULT OF 0.76 S/C (NON-REACTIVE). VERSUS THE EXPECTED RESULT OF REACTIVE SAMPLE (B)(6), RESULT OF 0.82 S/C (NON-REACTIVE.) VERSUS THE EXPECTED RESULT OF REACTIVE SAMPLE (B)(6), RESULT OF 0.76 S/C (NON-REACTIVE.) VERSUS THE EXPECTED RESULT OF REACTIVE VITROS HBSAG LOT 3551 RESULTS: SAMPLE (B)(6), RESULT OF 0.59 S/C (NON-REACTIVE) VERSUS THE EXPECTED RESULT OF REACTIVE SAMPLE (B)(6), RESULT OF 0.50 S/C (NON-REACTIVE) VERSUS THE EXPECTED RESULT OF REACTIVE SAMPLE (B)(6), RESULT OF 0.70 S/C (NON-REACTIVE) VERSUS THE EXPECTED RESULT OF REACTIVE BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. THE DISCORDANT, NON-REACTIVE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20820014 ↗
• MalfunctionDec 2, 2024False Negative Result; False Negative Result

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT DISCORDANT, NON-REACTIVE HBSAG RESULTS WERE OBTAINED WHEN NON-VITROS EXTERNAL QUALITY ASSESSMENT (EQA) PROFICIENCY SAMPLES WERE TESTED USING VITROS HBSAG ES LOT 3530 AND LOT 3551 ON A VITROS 3600 IMMUNODIAGNOSTIC SYSTEM. THE RESULTS WERE DISCORDANT WHEN COMPARED TO HBSAG RESULTS FROM NON-VITROS (ABBOTT AND SYSMEX) METHODS. VITROS HBSAG LOT 3530 RESULTS: SAMPLE (B)(6), RESULT OF 0.76 S/C (NON-REACTIVE) VERSUS THE EXPECTED RESULT OF REACTIVE SAMPLE (B)(6), RESULT OF 0.82 S/C (NON-REACTIVE) VERSUS THE EXPECTED RESULT OF REACTIVE SAMPLE (B)(6), RESULT OF 0.76 S/C (NON-REACTIVE) VERSUS THE EXPECTED RESULT OF REACTIVE VITROS HBSAG LOT 3551 RESULTS: SAMPLE (B)(6), RESULT OF 0.59 S/C (NON-REACTIVE) VERSUS THE EXPECTED RESULT OF REACTIVE SAMPLE (B)(6), RESULT OF 0.50 S/C (NON-REACTIVE) VERSUS THE EXPECTED RESULT OF REACTIVE SAMPLE (B)(6), RESULT OF 0.70 S/C (NON-REACTIVE) VERSUS THE EXPECTED RESULT OF REACTIVE BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. THE DISCORDANT, NON-REACTIVE VIT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20819830 ↗
• MalfunctionNov 9, 2023False Negative Result; False Negative Result

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT FALSE NEGATIVE VITROS HBSAG RESULTS WERE OBTAINED WHEN TESTED USING NON-VITROS EXTERNAL QUALITY ASSESSMENT (EQA) PROFICIENCY FLUIDS WHEN USING VITROS HBSAG REAGENT LOT 3460 ON A VITROS 3600 IMMUNODIAGNOSTIC SYSTEM. EQA SAMPLE 231H-12 RESULTS OF 0.07 AND 0.08 (NON-REACTIVE) S/C VS. EXPECTED RESULT OF 2.23 AND 2.35 S/C (REACTIVE). EQA SAMPLE 231H-16 RESULTS OF 0.19 AND 0.18 (NON-REACTIVE) S/C VS. EXPECTED RESULT OF 1.69 AND 1.78 S/C(REACTIVE). EQA SAMPLE 231H-20 RESULTS OF 0.57 AND 0.60 (NON-REACTIVE) S/C VS. EXPECTED RESULT OF 3.58 AND 3.78 S/C (REACTIVE). 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 NEGATIVE VITROS HBSAG RESULTS WERE OBTAINED FROM A NON-PATIENT FLUID. THE CUSTOMER DID NOT INDICATE THAT ANY UNEXPECTED VITROS HBSAG RESULTS WERE OBTAINED FOR PATIENT SAMPLES AT THE TIME OF THE EVENT OR OVER THE COURSE OF THE INVESTIGATION AND THERE ARE NO REPORTED ALLEGATIONS OF PATIENT HARM. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMB

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18104573 ↗
• MalfunctionMar 24, 2023False Negative Result; False Negative Result

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT DISCORDANT, NEGATIVE HBSAG RESULTS WERE OBTAINED WHEN WISCONSIN STATE LABORATORY OF HYGIENE (WSLH) PROFICIENCY SAMPLES WERE TESTED USING VITROS HBSAG LOT 9000, LOT 9020 AND LOT 9130 FROM THREE SEPARATE PROFICIENCY TESTING EVENTS ON A VITROS ECI Q IMMUNODIAGNOSTIC SYSTEM. VITROS HBSAG LOT 9000, WSLH SAMPLE YB-6 RESULT OF 0.03 S/C (NEGATIVE) VERSUS THE EXPECTED RESULT OF POSITIVE VITROS HBSAG LOT 9000, WSLH SAMPLE YB-7 RESULT OF 0.45 S/C (NEGATIVE) VERSUS THE EXPECTED RESULT OF POSITIVE VITROS HBSAG LOT 9020, WSLH SAMPLE YB-14 RESULT OF 0.51 S/C (NEGATIVE) VERSUS THE EXPECTED RESULT OF POSITIVE VITROS HBSAG LOT 9130, WSLH SAMPLE YB-5 RESULT OF 0.02 S/C (NEGATIVE) VERSUS THE EXPECTED RESULT OF POSITIVE BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. THE DISCORDANT, NEGATIVE VITROS HBSAG RESULTS WERE GENERATED WHEN THE CUSTOMER WAS RUNNING NON-PATIENT FLUIDS. ORTHO HAS NOT BEEN MADE AWARE OF ANY ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER FOUR OF FOUR M

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16608273 ↗
• MalfunctionMar 24, 2023False Negative Result; False Negative Result

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT DISCORDANT, NEGATIVE HBSAG RESULTS WERE OBTAINED WHEN WISCONSIN STATE LABORATORY OF HYGIENE (WSLH) PROFICIENCY SAMPLES WERE TESTED USING VITROS HBSAG LOT 9000, LOT 9020 AND LOT 9130 FROM THREE SEPARATE PROFICIENCY TESTING EVENTS ON A VITROS ECI Q IMMUNODIAGNOSTIC SYSTEM. VITROS HBSAG LOT 9000, WSLH SAMPLE YB-6 RESULT OF 0.03 S/C (NEGATIVE) VERSUS THE EXPECTED RESULT OF POSITIVE VITROS HBSAG LOT 9000, WSLH SAMPLE YB-7 RESULT OF 0.45 S/C (NEGATIVE) VERSUS THE EXPECTED RESULT OF POSITIVE VITROS HBSAG LOT 9020, WSLH SAMPLE YB-14 RESULT OF 0.51 S/C (NEGATIVE) VERSUS THE EXPECTED RESULT OF POSITIVE VITROS HBSAG LOT 9130, WSLH SAMPLE YB-5 RESULT OF 0.02 S/C (NEGATIVE) VERSUS THE EXPECTED RESULT OF POSITIVE BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. THE DISCORDANT, NEGATIVE VITROS HBSAG RESULTS WERE GENERATED WHEN THE CUSTOMER WAS RUNNING NON-PATIENT FLUIDS. ORTHO HAS NOT BEEN MADE AWARE OF ANY ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER THREE OF FOUR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16608271 ↗
• MalfunctionMar 24, 2023False Negative Result; False Negative Result

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT DISCORDANT, NEGATIVE HBSAG RESULTS WERE OBTAINED WHEN WISCONSIN STATE LABORATORY OF HYGIENE (WSLH) PROFICIENCY SAMPLES WERE TESTED USING VITROS HBSAG LOT: 9000, LOT: 9020 AND LOT: 9130 FROM THREE SEPARATE PROFICIENCY TESTING EVENTS ON A VITROS ECI Q IMMUNODIAGNOSTIC SYSTEM. VITROS HBSAG LOT 9000, WSLH SAMPLE YB-6 RESULT OF 0.03 S/C (NEGATIVE) VERSUS THE EXPECTED RESULT OF POSITIVE VITROS HBSAG LOT 9000, WSLH SAMPLE YB-7 RESULT OF 0.45 S/C (NEGATIVE) VERSUS THE EXPECTED RESULT OF POSITIVE VITROS HBSAG LOT: 9020, WSLH SAMPLE YB-14 RESULT OF 0.51 S/C (NEGATIVE) VERSUS THE EXPECTED RESULT OF POSITIVE VITROS HBSAG LOT 9130, WSLH SAMPLE YB-5 RESULT OF 0.02 S/C (NEGATIVE) VERSUS THE EXPECTED RESULT OF POSITIVE BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. THE DISCORDANT, NEGATIVE VITROS HBSAG RESULTS WERE GENERATED WHEN THE CUSTOMER WAS RUNNING NON-PATIENT FLUIDS. ORTHO HAS NOT BEEN MADE AWARE OF ANY ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER TWO OF FOU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16608267 ↗
• MalfunctionMar 24, 2023False Negative Result; False Negative Result

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT DISCORDANT, NEGATIVE HBSAG RESULTS WERE OBTAINED WHEN WISCONSIN STATE LABORATORY OF HYGIENE (WSLH) PROFICIENCY SAMPLES WERE TESTED USING VITROS HBSAG LOT 9000, LOT 9020 AND LOT 9130 FROM THREE SEPARATE PROFICIENCY TESTING EVENTS ON A VITROS ECI Q IMMUNODIAGNOSTIC SYSTEM. VITROS HBSAG LOT 9000, WSLH SAMPLE YB-6 RESULT OF 0.03 S/C (NEGATIVE) VERSUS THE EXPECTED RESULT OF POSITIVE VITROS HBSAG LOT 9000, WSLH SAMPLE YB-7 RESULT OF 0.45 S/C (NEGATIVE) VERSUS THE EXPECTED RESULT OF POSITIVE VITROS HBSAG LOT 9020, WSLH SAMPLE YB-14 RESULT OF 0.51 S/C (NEGATIVE) VERSUS THE EXPECTED RESULT OF POSITIVE VITROS HBSAG LOT 9130, WSLH SAMPLE YB-5 RESULT OF 0.02 S/C (NEGATIVE) VERSUS THE EXPECTED RESULT OF POSITIVE BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. THE DISCORDANT, NEGATIVE VITROS HBSAG RESULTS WERE GENERATED WHEN THE CUSTOMER WAS RUNNING NON-PATIENT FLUIDS. ORTHO HAS NOT BEEN MADE AWARE OF ANY ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER ONE OF FOUR MD

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16608262 ↗