VITROS 6842781Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10758750031580), received between Nov 30, 2022 and Mar 16, 2026 — classified as 16 malfunctions.

The most frequently reported specific device problem is “False Negative Result” (14 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 16, 2026False Negative Result

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT DISCORDANT, NEGATIVE VITROS HIVC RESULTS WERE OBTAINED FROM TWO DIFFERENT LEVELS OF VITROS ANTI-HIV 1+2 LOT 1231 CONTROLS AND FROM PATIENT SAMPLES WHEN TESTED USING VITROS HIVC LOT 1310 ON A VITROS 3600 IMMUNODIAGNOSTIC SYSTEM. VITROS ANTI-HIV 1+2 LOT 1231 C2 CONTROL VITROS HIVC RESULT OF 0.023 S/C (NEGATIVE) VS. THE EXPECTED RESULT OF 24.4 S/C (REACTIVE) VITROS ANTI-HIV 1+2 LOT 1231 C3 CONTROL VITROS HIVC RESULT OF 0.019 S/C (NEGATIVE) VS. THE EXPECTED. RESULT OF 43.6 S/C (REACTIVE) PATIENT SAMPLE A HIVC RESULT OF 0.03 S/C (NEGATIVE) VS. THE EXPECTED. RESULT OF 128.0 (REACTIVE) PATIENT SAMPLE 1 HIVC RESULT OF 0.02 S/C (NEGATIVE) VS. THE EXPECTED. RESULT OF 227.0 (REACTIVE) PATIENT SAMPLE 2 HIVC RESULT OF 0.03 S/C (NEGATIVE) VS. THE EXPECTED. RESULT OF 128.0 (REACTIVE) PATIENT SAMPLE 3 HIVC RESULT OF 0.03 S/C (NEGATIVE) VS. THE EXPECTED. RESULT OF 159.0 (REACTIVE) PATIENT SAMPLE 4 HIVC RESULT OF 0.03 S/C (NEGATIVE) VS. THE EXPECTED. RESULT OF 152.0 (REACTIVE) THE DISCORDANT, FALSE NEGATIVE RESULTS WERE OBTAINED FROM TWO LEVELS OF QC FLUID AND FROM PATIENT SAMPLES THAT WERE PROCESSE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24603966 ↗
• MalfunctionJul 17, 2025False Negative Result; Incorrect Measurement; False Negative Result; Incorrect Measurement

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A DISCORDANT, NON-REACTIVE (NEGATIVE) VITROS HIVC RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE PROCESSED USING VITROS IMMUNODIAGNOSTIC PRODUCTS HIV COMBO (HIVC) REAGENT LOT 1230 ON A VITROS XT 7600 INTEGRATED SYSTEM. THE RESULT WAS CONSIDERED DISCORDANT WHEN COMPARED TO THE RESULT USING A NON-VITROS BIOMERIEUX VIDAS HIV DUO AG/AB METHOD OBTAINED FROM THE SAME SAMPLE. PATIENT SAMPLE RESULT OF 0.12 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. THE NON-REACTIVE VITROS HIVC 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 22529891 ↗
• MalfunctionJul 11, 2025False Negative Result; Low Test Results; False Negative Result; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT THAT DISCORDANT NEGATIVE VITROS HIV COMBO (HIVC) RESULTS WERE OBTAINED FROM TWO DIFFERENT LEVELS OF VITROS ANTI-HIV 1+2 LOT 1160 CONTROLS AND DISCORDANT NEGATIVE VITROS HEPATITIS C VIRUS (HCV) RESULTS WERE OBTAINED FROM A SINGLE LEVEL OF VITROS ANTI-HCV LOT 1580 CONTROL. THE RESULTS WERE OBTAINED WHEN TESTED ON A VITROS 3600 IMMUNODIAGNOSTIC SYSTEM. VITROS ANTI-HIV 1+2 LOT 1160 L2 CONTROL VITROS HIVC RESULTS OF 0.22, 0.23, 0.24 AND 0.18 S/C (NEGATIVE) VS. THE EXPECTED RESULT OF >/=1.00 S/C (REACTIVE). VITROS ANTI-HIV 1+2 LOT 1160 L3 CONTROL VITROS HIVC RESULT OF 0.13 S/C (NEGATIVE) VS. THE EXPECTED RESULT OF >/=1.00 S/C (REACTIVE). VITROS ANTI-HCV LOT 1580 REACTIVE CONTROL VITROS AHCV REAGENT LOT 5810 RESULTS OF 0.080, 0.060, 0.049, 0.025, 0.009 AND 0.018 S/C (NEGATIVE) VS. THE EXPECTED RESULT OF >/=1.00 S/C (REACTIVE). BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER ONE OF TWO 3500A FORMS ARE BEING SUBMITTED FO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22479701 ↗
• MalfunctionDec 4, 2024False Negative Result; False Negative Result

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT DISCORDANT, NON-REACTIVE VITROS HIV COMBO (HIVC) RESULTS WERE OBTAINED FROM A BLOOD BANK DONOR SAMPLE WHEN TESTED USING VITROS HIVC LOT 1070 IN COMBINATION WITH A VITROS 3600 IMMUNODIAGNOSTIC SYSTEM. SAMPLE 2 RESULTS OF 0.65 AND 0.66 S/C (NEGATIVE) 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. THE NON-REACTIVE VITROS HIVC RESULTS WERE OBTAINED FROM BLOOD BANK DONOR SAMPLE AND 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 20848200 ↗
• MalfunctionSep 16, 2024False Positive Result; False Positive Result

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT REPRODUCIBLE DISCORDANT REACTIVE VITROS HIV COMBO RESULTS FROM A PATIENT SAMPLE FROM A BIRTHING MOTHER AND A PATIENT SAMPLE FROM THE NEWBORN BABY WHEN USING A VITROS IMMUNODIAGNOSTIC PRODUCTS HIV COMBO (HIVC) REAGENT WITH A VITROS 5600 INTEGRATED SYSTEM. FALSE POSITIVE VITROS HIV COMBO RESULTS ARE NOT A VITROS POTENTIAL HEALTH AND SAFETY CRITERIA. HOWEVER, AS UNKNOWN TREATMENT WAS ADMINISTERED TO BOTH THE MOTHER AND THE NEWBORN BABY BASED ON THE VITROS RESULTS, THIS CONSTITUTES A POTENTIAL HEALTH AND SAFETY COMPLAINT AND IS REPORTABLE. MOTHER SAMPLE RESULTS OF 1.38, 1.31 AND 1.38 S/C (REACTIVE) VERSUS THE EXPECTED RESULT OF NEGATIVE BABY SAMPLE RESULTS OF 1.91, 1.95 AND 1.95 S/C(REACTIVE) VERSUS 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, REACTIVE VITROS HIVC RESULTS FOR THE MOTHER AND THE NEWBORN BABY WERE REPORTED OUTSIDE THE LABORATORY. BASED ON THE VITROS RESULTS, UNKNOWN TREATMENT WAS ADMINISTERED TO BOTH THE MOTHER AND THE NEWBORN BABY. HOWEV

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20229684 ↗
• MalfunctionSep 16, 2024False Positive Result; False Positive Result

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT REPRODUCIBLE DISCORDANT REACTIVE VITROS HIV COMBO RESULTS FROM A PATIENT SAMPLE FROM A BIRTHING MOTHER AND A PATIENT SAMPLE FROM THE NEWBORN BABY WHEN USING A VITROS IMMUNODIAGNOSTIC PRODUCTS HIV COMBO (HIVC) REAGENT WITH A VITROS 5600 INTEGRATED SYSTEM. FALSE POSITIVE VITROS HIV COMBO RESULTS ARE NOT A VITROS POTENTIAL HEALTH AND SAFETY CRITERIA. HOWEVER, AS UNKNOWN TREATMENT WAS ADMINISTERED TO BOTH THE MOTHER AND THE NEWBORN BABY BASED ON THE VITROS RESULTS, THIS CONSTITUTES A POTENTIAL HEALTH AND SAFETY COMPLAINT AND IS REPORTABLE. MOTHER SAMPLE RESULTS OF 1.38, 1.31 AND 1.38 S/C (REACTIVE) VERSUS THE EXPECTED RESULT OF NEGATIVE BABY SAMPLE RESULTS OF 1.91, 1.95 AND 1.95 S/C(REACTIVE) VERSUS 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, REACTIVE VITROS HIVC RESULTS FOR THE MOTHER AND THE NEWBORN BABY WERE REPORTED OUTSIDE THE LABORATORY. BASED ON THE VITROS RESULTS, UNKNOWN TREATMENT WAS ADMINISTERED TO BOTH THE MOTHER AND THE NEWBORN BABY. HOWEV

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20228562 ↗
• MalfunctionJan 10, 2024False Negative Result; False Negative Result

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT DISCORDANT NON-REACTIVE VITROS HIV COMBO RESULTS WERE OBTAINED FROM A REACTIVE VITROS HIV P24 ANTIGEN QC FLUID LOT 0150 WHEN USING VITROS IMMUNODIAGNOSTICS PRODUCTS HIV COMBO (HIVC) REAGENT LOT 0950 IN CONJUNCTION WITH A VITROS 3600 IMMUNODIAGNOSTIC SYSTEM. VITROS HIV P24 ANTIGEN QC RESULTS OF 0.49, 0.60 AND 0.84 S/C (NEGATIVE) VS. 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 VITROS HIV COMBO RESULTS WERE FROM NON-PATIENT FLUID AND WERE NOT REPORTED OUTSIDE 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 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18483490 ↗
• MalfunctionJan 9, 2024False Negative Result; False Negative Result

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT DISCORDANT NON-REACTIVE VITROS HIV COMBO (HIVC) RESULTS WERE OBTAINED WHEN AN ORTHO LABORATORY SPECIALIST (LS) WAS PROCESSING VITROS HIV P24 ANTIGEN CONTROL LOT 0150 WHEN COMPLETING INSTALLATION OF A VITROS 3600 INTEGRATED SYSTEM AT THE CUSTOMER SITE. THE ORTHO LS WAS PROCESSING VITROS HIV P24 ANTIGEN CONTROLS WHEN USING VITROS IMMUNODIAGNOSTICS PRODUCTS HIVC REAGENT LOT 0970. VITROS HIV P24 ANTIGEN CONTROL RESULT OF 0.62, 0.62 AND 0.67 S/C (NEGATIVE) VS. 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 FALSE NEGATIVE VITROS HIVC RESULTS WERE OBTAINED WHEN A NON-PATIENT FLUID WAS PROCESSED WHEN AN ORTHO LS WAS INSTALLING THE VITROS 3600 IMMUNODIAGNOSTIC SYSTEM AT THE CUSTOMER SITE. 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 604580.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18480233 ↗
• MalfunctionSep 12, 2023False Negative Result; False Negative Result

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT REPRODUCIBLE, DISCORDANT FALSE NEGATIVE VITROS HIV COMBO (HIVC) RESULTS WERE OBTAINED FROM A SINGLE PATIENT SAMPLE WHEN TESTED ON A VITROS 3600 IMMUNODIAGNOSTIC SYSTEM. THE RESULTS WERE CONSIDERED DISCORDANT WHEN COMPARED TO REACTIVE RESULTS OBTAINED FROM THE SAME PATIENT SAMPLE WHEN TESTED USING NON-VITROS METHODS. PATIENT SAMPLE 1 RESULTS OF 0.37 AND 0.40 S/C (NEGATIVE) 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. THE DISCORDANT, NEGATIVE VITROS HIVC RESULTS WERE NOT REPORTED OUTSIDE 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 603042.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17728098 ↗
• MalfunctionMay 25, 2023False Negative Result; False Negative Result

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT DISCORDANT, FALSE NEGATIVE HIV COMBO (HIVC) RESULTS WERE OBTAINED WHEN TWO DIFFERENT SAMPLES COLLECTED FROM A SINGLE DONOR (DONOR SAMPLE 1 AND DONOR SAMPLE 2) AND A WEAK REACTIVE CONTROL 1 WAS TESTED USING VITROS HIVC LOT 0820 ON A VITROS 3600 IMMUNODIAGNOSTIC SYSTEM. THE DONOR SAMPLE 1 RESULT WAS DISCORDANT WHEN COMPARED TO REACTIVE VITROS HIVC RESULT OBTAINED USING REAGENT LOT 0790 FOR SAME PATIENT SAMPLE. DISCORDANT, FALSE NEGATIVE HIVC RESULTS WERE OBTAINED WHEN A SECOND SAMPLE COLLECTED FROM THE SAME DONOR (DONOR SAMPLE 2) WAS TESTED USING VITROS HIVC LOT 0830 ON THE SAME VITROS 3600 IMMUNODIAGNOSTIC SYSTEM. DONOR SAMPLE 1, VITROS HIVC LOT 0820 RESULTS OF 0.62, 0.70 AND 0.89 S/C (NEGATIVE) VERSUS THE LOT 0790 REACTIVE RESULTS. CUSTOMER¿S WEAK REACTIVE CONTROL 1, VITROS HIVC LOT 0820 RESULTS 0.37 AND 0.87 S/C VERSUS AN EXPECTED REACTIVE RESULT. DONOR SAMPLE 2, VITROS HIVC LOT 0830 RESULTS OF 0.34, 0.16 AND 0.24 S/C (NEGATIVE) VERSUS THE EXPECTED REACTIVE RESULTS. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17000595 ↗
• MalfunctionMay 25, 2023False Negative Result; False Negative Result

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT DISCORDANT, FALSE NEGATIVE HIV COMBO (HIVC) RESULTS WERE OBTAINED WHEN TWO DIFFERENT SAMPLES COLLECTED FROM A SINGLE DONOR (DONOR SAMPLE 1 AND DONOR SAMPLE 2) AND A WEAK REACTIVE CONTROL 1 WAS TESTED USING VITROS HIVC LOT 0820 ON A VITROS 3600 IMMUNODIAGNOSTIC SYSTEM. THE DONOR SAMPLE 1 RESULT WAS DISCORDANT WHEN COMPARED TO REACTIVE VITROS HIVC RESULT OBTAINED USING REAGENT LOT 0790 FOR SAME PATIENT SAMPLE. DISCORDANT, FALSE NEGATIVE HIVC RESULTS WERE OBTAINED WHEN A SECOND SAMPLE COLLECTED FROM THE SAME DONOR (DONOR SAMPLE 2) WAS TESTED USING VITROS HIVC LOT 0830 ON THE SAME VITROS 3600 IMMUNODIAGNOSTIC SYSTEM. DONOR SAMPLE 1, VITROS HIVC LOT 0820 RESULTS OF 0.62, 0.70 AND 0.89 S/C (NEGATIVE) VERSUS THE LOT 0790 REACTIVE RESULTS. CUSTOMER¿S WEAK REACTIVE CONTROL 1, VITROS HIVC LOT 0820 RESULTS 0.37 AND 0.87 S/C VERSUS AN EXPECTED REACTIVE RESULT. DONOR SAMPLE 2, VITROS HIVC LOT 0830 RESULTS OF 0.34, 0.16 AND 0.24 S/C (NEGATIVE) VERSUS THE EXPECTED REACTIVE RESULTS. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17000582 ↗
• MalfunctionFeb 23, 2023False Negative Result; False Negative Result

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A DISCORDANT, FALSE NEGATIVE HIVC RESULT WAS OBTAINED WHEN A SAMPLE FROM A SINGLE PATIENT WAS TESTED USING VITROS HIVC LOT 0761 ON A VITROS 3600 IMMUNODIAGNOSTIC SYSTEM. THE RESULT WAS DISCORDANT WHEN COMPARED TO REACTIVE VITROS HIVC RESULT OBTAINED USING REAGENT LOT 0790 FOR SAME PATIENT SAMPLE. PATIENT 1 SAMPLE, VITROS HIVC LOT 0761 RESULT OF 0.18 S/C (NEGATIVE) VERSUS THE LOT 0790 RESULT OF 1.09 S/C (REACTIVE) BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE VITROS HIVC DISCORDANT NEGATIVE RESULT OBTAINED FROM THE PATIENT 1 SAMPLE WAS NOT REPORTED OUTSIDE THE LABORATORY AND THERE WAS NO REPORTED 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 16430499 ↗
• MalfunctionDec 20, 2022False Negative Result; False Negative Result

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT DISCORDANT, NEGATIVE VITROS HIV COMBO (HIVC) LOT 0460 RESULTS WERE OBTAINED FROM PATIENT SPECIMENS WHEN TESTED ON TWO VITROS 5600 INTEGRATED SYSTEMS. THE VITROS HIVC RESULTS WERE DISCORDANT COMPARED TO NON-VITROS (LATERAL FLOW) METHOD RESULTS AND VITROS HIVC REPEAT RESULTS FOR THE SAMPLES. SPECIMEN 4, VITROS HIVC INITIAL RESULTS OF 0.09 AND 0.15 S/C (NEGATIVE), VITROS HIVC REPEAT RESULTS OF 0.35 AND 0.17 S/C (NEGATIVE) VERSUS A POSITIVE LATERAL FLOW RESULT SPECIMEN 10, VITROS HIVC INITIAL RESULTS OF 0.12 AND 0.11 S/C (NEGATIVE) VERSUS A POSITIVE LATERAL FLOW RESULT AND REPEAT VITROS HIVC RESULTS OF 1.86 AND 1.64 (REACTIVE) SPECIMEN 17, VITROS HIVC INITIAL RESULTS OF 0.07 AND 0.13 S/C (NEGATIVE) VERSUS A POSITIVE LATERAL FLOW RESULT AND REPEAT VITROS HIVC RESULTS OF 6.79 AND 6.36 S/C (REACTIVE) SPECIMEN 18, VITROS HIVC INITIAL RESULTS OF 0.14 AND 0.20 S/C (NEGATIVE) VERSUS A POSITIVE LATERAL FLOW RESULT AND REPEAT VITROS HIVC RESULTS OF 56.57 AND 47.26 S/C (REACTIVE) THE DISCORDANT, NEGATIVE VITROS HIVC RESULTS WERE NOT REPORTED FROM THE LABORATORY AS THE VITROS HIVC REAGENT METHOD

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16015048 ↗
• MalfunctionDec 20, 2022False Negative Result; False Negative Result

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT DISCORDANT, NEGATIVE VITROS HIV COMBO (HIVC) LOT: 0460 RESULTS WERE OBTAINED FROM PATIENT SPECIMENS WHEN TESTED ON TWO VITROS 5600 INTEGRATED SYSTEMS. THE VITROS HIVC RESULTS WERE DISCORDANT COMPARED TO NON-VITROS (LATERAL FLOW) METHOD RESULTS AND VITROS HIVC REPEAT RESULTS FOR THE SAMPLES. SPECIMEN 4, VITROS HIVC INITIAL RESULTS OF 0.09 AND 0.15 S/C (NEGATIVE), VITROS HIVC REPEAT RESULTS OF 0.35 AND 0.17 S/C (NEGATIVE) VERSUS A POSITIVE LATERAL FLOW RESULT SPECIMEN 10, VITROS HIVC INITIAL RESULTS OF 0.12 AND 0.11 S/C (NEGATIVE) VERSUS A POSITIVE LATERAL FLOW RESULT AND REPEAT VITROS HIVC RESULTS OF 1.86 AND 1.64 (REACTIVE) SPECIMEN 17, VITROS HIVC INITIAL RESULTS OF 0.07 AND 0.13 S/C (NEGATIVE) VERSUS A POSITIVE LATERAL FLOW RESULT AND REPEAT VITROS HIVC RESULTS OF 6.79 AND 6.36 S/C (REACTIVE) SPECIMEN 18, VITROS HIVC INITIAL RESULTS OF 0.14 AND 0.20 S/C (NEGATIVE) VERSUS A POSITIVE LATERAL FLOW RESULT AND REPEAT VITROS HIVC RESULTS OF 56.57 AND 47.26 S/C (REACTIVE) THE DISCORDANT, NEGATIVE VITROS HIVC RESULTS WERE NOT REPORTED FROM THE LABORATORY AS THE VITROS HIVC REAGENT METHOD

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16015040 ↗
• MalfunctionNov 30, 2022False Negative Result; False Negative Result

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT DISCORDANT, FALSE NEGATIVE HIVC RESULTS WERE OBTAINED WHEN MULTIPLE SAMPLES WERE TESTED USING VITROS HIVC LOT 0730 AND LOT 0810 ON A VITROS XT7600 INTEGRATED SYSTEM. THE TESTING WAS CONDUCTED AS PART OF INTERNAL INVESTIGATIONAL TESTING AT ORTHO ROCHESTER. SAMPLE 1, VITROS HIVC LOT 0730 RESULT OF 0.78 S/C (NEGATIVE) AND VITROS HIVC LOT 0810 RESULT OF 0.62 S/C (NEGATIVE) VERSUS THE EXPECTED RESULT OF REACTIVE SAMPLE 2, VITROS HIVC LOT 0730 RESULT OF 0.30 S/C (NEGATIVE) AND VITROS HIVC LOT 0810 RESULT OF 0.12 S/C (NEGATIVE) VERSUS THE EXPECTED RESULT OF REACTIVE SAMPLE 3, VITROS HIVC LOT 0730 RESULT OF 0.21 S/C (NEGATIVE) AND VITROS HIVC LOT 0810 RESULT OF 0.13 S/C (NEGATIVE) VERSUS THE EXPECTED RESULT OF REACTIVE SAMPLE 4, VITROS HIVC LOT 0730 RESULT OF 0.25 S/C (NEGATIVE) AND VITROS HIVC LOT 0810 RESULT OF 0.16 S/C (NEGATIVE) VERSUS THE EXPECTED RESULT OF REACTIVE SAMPLE 5, VITROS HIVC LOT 0730 RESULT OF 0.23 S/C (NEGATIVE) AND VITROS HIVC LOT 0810 RESULT OF 0.15 S/C (NEGATIVE) VERSUS THE EXPECTED RESULT OF REACTIVE BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15887227 ↗
• MalfunctionNov 30, 2022False Negative Result; False Negative Result

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT DISCORDANT, FALSE NEGATIVE HIVC RESULTS WERE OBTAINED WHEN MULTIPLE SAMPLES WERE TESTED USING VITROS HIVC LOT 0730 AND LOT 0810 ON A VITROS XT7600 INTEGRATED SYSTEM. THE TESTING WAS CONDUCTED AS PART OF INTERNAL INVESTIGATIONAL TESTING AT ORTHO ROCHESTER. SAMPLE 1, VITROS HIVC LOT 0730 RESULT OF 0.78 S/C (NEGATIVE) AND VITROS HIVC LOT 0810 RESULT OF 0.62 S/C (NEGATIVE) VERSUS THE EXPECTED RESULT OF REACTIVE SAMPLE 2, VITROS HIVC LOT 0730 RESULT OF 0.30 S/C (NEGATIVE) AND VITROS HIVC LOT 0810 RESULT OF 0.12 S/C (NEGATIVE) VERSUS THE EXPECTED RESULT OF REACTIVE SAMPLE 3, VITROS HIVC LOT 0730 RESULT OF 0.21 S/C (NEGATIVE) AND VITROS HIVC LOT 0810 RESULT OF 0.13 S/C (NEGATIVE) VERSUS THE EXPECTED RESULT OF REACTIVE SAMPLE 4, VITROS HIVC LOT 0730 RESULT OF 0.25 S/C (NEGATIVE) AND VITROS HIVC LOT 0810 RESULT OF 0.16 S/C (NEGATIVE) VERSUS THE EXPECTED RESULT OF REACTIVE SAMPLE 5, VITROS HIVC LOT 0730 RESULT OF 0.23 S/C (NEGATIVE) AND VITROS HIVC LOT 0810 RESULT OF 0.15 S/C (NEGATIVE) VERSUS THE EXPECTED RESULT OF REACTIVE BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15887166 ↗