VITROS 6802220Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 10758750002320), received between Feb 10, 2023 and May 15, 2026 — classified as 24 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 15, 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 B-HCG RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE WHEN USING VITROS IMMUNODIAGNOSTICS PRODUCT B-HCG II, REAGENT LOT 4910, ON A VITROS XT 7600 INTEGRATED SYSTEM. THE RESULT WAS CONSIDERED DISCORDANT WHEN A REPEAT TEST WAS PERFORMED USING THE SAME SAMPLE. PATIENT 1, SAMPLE 1 VITROS B-HCG II RESULT OF 1289.8 MIU/ML VS. THE EXPECTED SAMPLE 1 RESULT OF <2.4 MIU/ML BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE NON-REPRODUCIBLE, HIGHER THAN EXPECTED B-HCG II RESULT WAS REPORTED FROM THE LABORATORY AND QUESTIONED BY THE PHYSICIAN. HOWEVER, NO TREATMENT WAS INITIATED, ALTERED, OR STOPPED BASED ON THE REPORTED RESULT. 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 25184949 ↗
• MalfunctionMar 31, 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 B-HCG II RESULT OBTAINED WHEN A SINGLE PATIENT SAMPLE WAS TESTED USING VITROS IMMUNODIAGNOSTIC PRODUCTS TOTAL B HCG II REAGENT PACK II LOT: 4720 ON A VITROS 5600 INTEGRATED SYSTEM. PATIENT 1, SAMPLE 1 RESULT OF 193 MIU/ML VERSUS THE REPEAT VITROS B-HCG II RESULTS OF < 2.39 MIU/ML BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE NON-REPRODUCIBLE, HIGHER THAN EXPECTED VITROS B-HCG II RESULT WAS NOT REPORTED FROM THE LABORATORY. 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).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24747158 ↗
• MalfunctionMar 26, 2026High Test Results; Non Reproducible Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A HIGHER THAN EXPECTED B-HCG RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE WHEN USING VITROS IMMUNODIAGNOSTIC PRODUCT TOTAL B-HUMAN CHORIONIC GONADOTROPIN (TOT B-HCG) II, REAGENT LOT 4720, ON A VITROS 5600 INTEGRATED SYSTEM. PATIENT 1, SAMPLE 1 VITROS B-HCG II RESULT OF 44.05 MIU/ML VS. THE EXPECTED RESULT OF <2.39 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 B-HCG II RESULT WAS NOT REPORTED BY 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 613909.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24700240 ↗
• MalfunctionMar 5, 2026Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED B-HCG RESULTS WERE OBTAINED FROM TWO DIFFERENT SAMPLES FROM THE SAME PATIENT WHEN USING VITROS IMMUNODIAGNOSTICS PRODUCT B-HCG II, REAGENT LOT 4740, ON A VITROS 5600 INTEGRATED SYSTEM. PATIENT 1, SAMPLE 1 VITROS B-HCG II RESULT OF <2.39 MIU/ML VS. THE EXPECTED RESULT OF >15000 MIU/ML PATIENT 1, SAMPLE 2 VITROS B-HCG II RESULT OF <2.39 MIU/ML VS. THE EXPECTED RESULT OF >15000 MIU/ML BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE LOWER THAN EXPECTED B-HCG II RESULTS WERE NOT REPORTED BY 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) AND REPORTABILITY ASSESSMENT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24524010 ↗
• MalfunctionMar 5, 2026Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED B-HCG RESULTS WERE OBTAINED FROM TWO DIFFERENT SAMPLES FROM THE SAME PATIENT WHEN USING VITROS IMMUNODIAGNOSTICS PRODUCT B-HCG II, REAGENT LOT 4740, ON A VITROS 5600 INTEGRATED SYSTEM. PATIENT 1, SAMPLE 1 VITROS B-HCG II RESULT OF <2.39 MIU/ML VS. THE EXPECTED RESULT OF >15000 MIU/ML PATIENT 1, SAMPLE 2 VITROS B-HCG II RESULT OF <2.39 MIU/ML VS. THE EXPECTED RESULT OF >15000 MIU/ML BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE LOWER THAN EXPECTED B-HCG II RESULTS WERE NOT REPORTED BY 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 REPORTABILITY ASSESSMENT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24524000 ↗
• MalfunctionNov 20, 2025Low Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED B-HCG RESULTS WERE OBTAINED FROM A LEVEL 3 NON-VITROS MAS OMNI IMMUNE QUALITY CONTROL (QC) FLUID LOT OIM2612 WHEN TESTED USING A VITROS IMMUNODIAGNOSTICS PRODUCT TOTAL B-HCG II REAGENT LOT 4710 ON A VITROS XT 7600 INTEGRATED SYSTEM. MAS LOT OIM2612 LEVEL 3 QC FLUID RESULTS OF 317.63 AND 330.76 MIU/ML VS. THE EXPECTED RESULT OF 788.82 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 LOWER-THAN-EXPECTED VITROS B-HCG II RESULTS WERE FROM NON-PATIENT FLUID AND WERE NOT REPORTED FROM THE LABORATORY. THE CUSTOMER DID NOT GIVE ANY INDICATION THAT PATIENT RESULTS HAD BEEN AFFECTED, AND 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 612639.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23604312 ↗
• MalfunctionNov 17, 2025High Test Results; Non Reproducible Results; High 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 TOTAL B-HCG (BHCG) RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE PROCESSED USING VITROS IMMUNODIAGNOSTICS PRODUCTS TOTAL BHCG II REAGENT LOT 4490 IN COMBINATION WITH A VITROS 5600 INTEGRATED SYSTEM. PATIENT SAMPLE RESULT OF 25.51 MIU/ML VERSUS AN EXPECTED RESULT OF <2.39 MIU/ML BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE NON-REPRODUCIBLE, HIGHER THAN EXPECTED VITROS BHCG RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THERE IS 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 23572926 ↗
• MalfunctionMay 6, 2025Low Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A LOWER-THAN-EXPECTED TOTAL B-HCG II RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE WHEN USING VITROS IMMUNODIAGNOSTIC PRODUCTS TOTAL B-HCG II (B-HCG II) REAGENT ON A VITROS 3600 IMMUNODIAGNOSTIC SYSTEM. THE RESULT WAS CONSIDERED DISCORDANT WHEN COMPARED TO A NON-VITROS BECKMAN METHOD USING THE SAME PATIENT SAMPLE. PATIENT 1 VITROS B-HCG II RESULT OF <2.39 MIU/ML VS. THE EXPECTED RESULT OF 11.00 MIU/ML BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LED TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE LOWER-THAN-EXPECTED VITROS B-HCG RESULT WAS 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 21970668 ↗
• MalfunctionMar 14, 2025High Test Results; Non Reproducible Results; High 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 RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE USING VITROS B-HCG (BHCGII) REAGENT LOT 4310 ON A VITROS 5600 INTEGRATED SYSTEM. PATIENT SAMPLE VITROS BHCGII RESULT OF 28.7 MIU/ML VERSUS THE REPEAT RESULT OF < 2.39 MIU/ML BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. IT IS UNKNOWN IF THE HIGHER THAN EXPECTED VITROS BHCGII RESULT OF 28.7 MIU/ML WAS REPORTED OUTSIDE OF THE LABORATORY OR IF A CORRECT REPORT WAS ISSUED. HOWEVER, THE CUSTOMER CONFIRMED THAT THERE HAS BEEN NO ALLEGATION OF PATIENT HARM. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER (B)(4) AND REPORTABILITY ASSESSMENT 609211.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21610314 ↗
• MalfunctionDec 5, 2024High Test Results; Non Reproducible Results; High 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 B-HCG RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE WHEN USING VITROS IMMUNODIAGNOSTICS PRODUCT B-HCG II REAGENT ON A VITROS 5600 INTEGRATED SYSTEM. PATIENT 1 VITROS B-HCG II RESULT OF 203.690 MIU/ML VS. THE EXPECTED VITROS B-HCG II RESULT OF 0.230 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 VITROS B-HCG RESULT WAS 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 20859584 ↗
• MalfunctionNov 20, 2024High Test Results; High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A HIGHER THAN EXPECTED TOTAL B-HCG II (BHCG II) RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE WHEN USING VITROS IMMUNODIAGNOSTICS PRODUCTS BHCG II REAGENT IN COMBINATION WITH A VITROS 5600 INTEGRATED SYSTEM. PATIENT 1 RESULT OF 41.23 MIU/ML VERSUS EXPECTED RESULT OF < 2.39 MIU/ML BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE NON-REPRODUCIBLE, HIGHER THAN EXPECTED, VITROS BHCG RESULT WAS NOT REPORTED FROM THE LABORATORY AND 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 20741518 ↗
• MalfunctionJul 15, 2024Low Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED VITROS B-HCG RESULTS WERE OBTAINED FROM NON-VITROS MAS OMNI IMMUNE QUALITY CONTROL (QC) FLUIDS WHEN TESTED USING VITROS IMMUNODIAGNOSTICS PRODUCT B-HCG II REAGENTS ON A VITROS XT 7600 INTEGRATED SYSTEM. MAS QC LEVEL 1 RESULTS OF 4.640, 5.010, 4.790, 4.780, 2.390, 5.150, 5.070, 5.310, 4.790, 5.180, 5.410, 5.500, 5.550 AND 5.570 MIU/L VS THE EXPECTED RESULT OF 8.670 MIU/L 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 B-HCG RESULTS WERE FROM NON-PATIENT FLUID AND WERE NOT REPORTED FROM THE LABORATORY. THE CUSTOMER DID NOT GIVE ANY INDICATION THAT PATIENT RESULTS HAD BEEN AFFECTED 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 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19744823 ↗
• MalfunctionJul 15, 2024Low Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED VITROS B-HCG RESULTS WERE OBTAINED FROM NON-VITROS MAS OMNI IMMUNE QUALITY CONTROL (QC) FLUIDS WHEN TESTED USING VITROS IMMUNODIAGNOSTICS PRODUCT B-HCG II REAGENTS ON A VITROS XT 7600 INTEGRATED SYSTEM. MAS QC LEVEL 1 RESULTS OF 4.640, 5.010, 4.790, 4.780, 2.390, 5.150, 5.070, 5.310, 4.790, 5.180, 5.410, 5.500, 5.550 AND 5.570 MIU/L VS THE EXPECTED RESULT OF 8.670 MIU/L 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 B-HCG RESULTS WERE FROM NON-PATIENT FLUID AND WERE NOT REPORTED FROM THE LABORATORY. THE CUSTOMER DID NOT GIVE ANY INDICATION THAT PATIENT RESULTS HAD BEEN AFFECTED 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 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19744455 ↗
• MalfunctionMar 7, 2024High Test Results; High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A HIGHER THAN EXPECTED B-HCG RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE WHEN USING VITROS IMMUNODIAGNOSTICS PRODUCT B-HCG II REAGENT ON THREE (3) DIFFERENT VITROS XT 7600 INTEGRATED SYSTEMS. PATIENT 1 VITROS B-HCG II RESULT OF 72.60 MIU/L VS. THE EXPECTED VITROS B-HCG II RESULT OF <2.39 MIU/L. 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 B-HCG RESULT WAS 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 NUMBERS (B)(4) , AND REPORTABILITY ASSESSMENT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18857481 ↗
• MalfunctionJan 17, 2024High Test Results; High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER AND LOWER THAN EXPECTED VITROS B-HCG II RESULTS WERE OBTAINED FROM NON-VITROS MAS OMNI IMMUNE QUALITY CONTROL (QC) FLUIDS WHEN TESTED USING VITROS IMMUNODIAGNOSTICS PRODUCT B-HCG II REAGENTS ON A VITROS XT 7600 INTEGRATED SYSTEM. VITROS TOTAL B-HCG II, LOT 3920: MAS QC LEVEL 2 RESULTS OF 4.26 AND 4.86 MIU/L VS. THE EXPECTED RESULT OF 24.5 MIU/L. VITROS TOTAL B-HCG II, LOT 4000: MAS QC LEVEL 1 RESULTS OF 11.79, 11.25, 11.66, 11.43 AND 12.42 MIU/L VS. THE EXPECTED RESULT OF 5.1 MIU/L. 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 AND LOWER THAN EXPECTED VITROS B-HCG II RESULTS WERE OBTAINED WHEN THE CUSTOMER WAS PROCESSING NON-PATIENT FLUIDS. THE CUSTOMER DID NOT GIVE ANY INDICATION THAT PATIENT RESULTS HAD BEEN AFFECTED. 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 MDR¿S FOR THIS EVENT. TWO 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS TWO DEVICES WERE INVOLVED. THIS REPORT CORRES

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18525365 ↗
• MalfunctionJan 17, 2024Low Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER AND LOWER THAN EXPECTED VITROS B-HCG II RESULTS WERE OBTAINED FROM NON-VITROS MAS OMNI IMMUNE QUALITY CONTROL (QC) FLUIDS WHEN TESTED USING VITROS IMMUNODIAGNOSTICS PRODUCT B-HCG II REAGENTS ON A VITROS XT 7600 INTEGRATED SYSTEM. VITROS TOTAL B-HCG II, LOT 3920: MAS QC LEVEL 2 RESULTS OF 4.26 AND 4.86 MIU/L VS. THE EXPECTED RESULT OF 24.5 MIU/L. VITROS TOTAL B-HCG II, LOT 4000: MAS QC LEVEL 1 RESULTS OF 11.79, 11.25, 11.66, 11.43 AND 12.42 MIU/L VS. THE EXPECTED RESULT OF 5.1 MIU/L. 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 AND LOWER THAN EXPECTED VITROS B-HCG II RESULTS WERE OBTAINED WHEN THE CUSTOMER WAS PROCESSING NON-PATIENT FLUIDS. THE CUSTOMER DID NOT GIVE ANY INDICATION THAT PATIENT RESULTS HAD BEEN AFFECTED. 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 CORRES

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18525299 ↗
• MalfunctionOct 20, 2023Low Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A LOWER THAN EXPECTED VITROS TOTAL B-HCG II (BHCG) RESULT WAS OBTAINED FROM INITIAL TESTING OF A SINGLE PATIENT SAMPLE USING VITROS BHCG LOT 3780 ON A VITROS XT7600 INTEGRATED SYSTEM. THE RESULT WAS LOWER THAN EXPECTED WHEN COMPARED TO THE REPEAT RESULT USING THE SAME PATIENT SAMPLE RUN ON THE SAME VITROS XT 7600 SYSTEM. PATIENT SAMPLE 1 BHCG RESULT OF <2.39 MIU/ML VERSUS THE EXPECTED PATIENT SAMPLE 1 RESULT OF 8.8 MIU/ML. 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 BHCG RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. A CORRECTED REPORT WAS LATER ISSUED AND NO TREATMENT WAS STOPPED, STARTED OR ALTERED BASED ON THE LOWER THAN EXPECTED RESULT. 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 603553.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17975069 ↗
• MalfunctionJul 26, 2023Low Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED B-HCG II RESULTS WERE OBTAINED WHEN TWO API PROFICIENCY SAMPLES WERE TESTED USING VITROS B-HCG LOT 3580 ON A VITROS 5600 INTEGRATED SYSTEM. API FIRST (REMEDIAL) SURVEY, SAMPLE 1, VITROS B-HCG II RESULT OF <2.39 MIU/ML VERSUS THE MIDPOINT OF THE API RANGE OF 6.2 MIU/ML (API RANGE: 0.0 ¿ 12.4 MIU/ML) API FIRST (REMEDIAL) SURVEY, SAMPLE 5, VITROS B-HCG II RESULT OF <2.39 MIU/ML VERSUS THE MIDPOINT OF THE API RANGE OF 6.2 MIU/ML (API RANGE: 0.0 ¿ 12.4 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 LOWER THAN EXPECTED VITROS B-HCG RESULTS OF <2.39 MIU/ML WERE OBTAINED FROM NON-PATIENT SAMPLES. 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 17396852 ↗
• MalfunctionJul 12, 2023High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A NON-REPRODUCIBLE, DISCORDANT, HIGHER THAN EXPECTED VITROS B-HCG RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE WHEN TESTED USING VITROS B-HCG LOT 3660 ON A VITROS 5600 INTEGRATED SYSTEM. PATIENT 1 VITROS B-HCG RESULT OF 24.69 MIU/ML VERSUS THE EXPECTED RESULT OF 2.39 MIU/ML BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE NON-REPRODUCIBLE, HIGHER THAN EXPECTED VITROS B-HCG RESULT WAS NOT REPORTED FROM THE LABORATORY, AS THE CUSTOMER VERIFIED THE RESULT WITH THE MANUAL TEST AND REPORTED THE NEGATIVE RESULT FROM THE LABORATORY. NO TREATMENT WAS ALTERED, INITIATED OR STOPPED BASED ON THE INITIALLY REPORTED HIGHER THAN EXPECTED RESULT. 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 17309199 ↗
• MalfunctionMay 17, 2023Low Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A DISCORDANT, LOWER THAN EXPECTED B-HCG II (B-HCG) RESULT WAS OBTAINED WHEN A PATIENT SAMPLE WAS TESTED USING VITROS B-HCG LOT 3650 ON A VITROS ECI Q IMMUNODIAGNOSTIC SYSTEM. PATIENT 1, SAMPLE 1 RESULT OF < 2.39 MIU/ML VERSUS THE EXPECTED RESULT OF 100 MIU/ML BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE DISCORDANT, LOWER THAN EXPECTED VITROS B-HCG RESULT WAS 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) COMPLAINT NUMBER (B)(4) AND REPORTABILITY ASSESSMENT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16944931 ↗
• MalfunctionMar 28, 2023Low Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED VITROS NT PROBNP II (NTBNP II) RESULTS WERE OBTAINED FROM TWO DIFFERENT PATIENT SAMPLES WHEN TESTED USING VITROS NTBNP II LOT: 0039 ON A VITROS 5600 INTEGRATED SYSTEM AND A VITROS 3600 IMMUNODIAGNOSTIC SYSTEM. VITROS 5600: PATIENT 11 SAMPLE VITROS NTBNP II RESULT OF 232 PG/ML VS AN EXPECTED RESULT OF 2166 PG/ML PATIENT 20 SAMPLE VITROS NTBNP II RESULT OF 3810 PG/ML VS AN EXPECTED RESULT OF 6220 PG/ML VITROS 3600: PATIENT 11 SAMPLE VITROS NTBNP II RESULT OF 230 PG/ML VS AN EXPECTED RESULT OF 2166 PG/ML PATIENT 20 SAMPLE VITROS NTBNP II RESULT OF 3900 PG/ML VS AN EXPECTED RESULT OF 6220 PG/ML BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY AS THEY WERE OBTAINED DURING VALIDATION TESTING. THERE IS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER TWO 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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16629104 ↗
• MalfunctionMar 28, 2023Low Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED VITROS NT PROBNP II (NTBNP II) RESULTS WERE OBTAINED FROM TWO DIFFERENT PATIENT SAMPLES WHEN TESTED USING VITROS NTBNP II LOT 0039 ON A VITROS 5600 INTEGRATED SYSTEM AND A VITROS 3600 IMMUNODIAGNOSTIC SYSTEM. VITROS 5600: PATIENT 11 SAMPLE VITROS NTBNP II RESULT OF 232 PG/ML VS AN EXPECTED RESULT OF 2166 PG/ML. PATIENT 20 SAMPLE VITROS NTBNP II RESULT OF 3810 PG/ML VS AN EXPECTED RESULT OF 6220 PG/ML VITROS 3600: PATIENT 11 SAMPLE VITROS NTBNP II RESULT OF 230 PG/ML VS AN EXPECTED RESULT OF 2166 PG/ML. PATIENT 20 SAMPLE VITROS NTBNP II RESULT OF 3900 PG/ML VS AN EXPECTED RESULT OF 6220 PG/ML. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY AS THEY WERE OBTAINED DURING VALIDATION TESTING. THERE IS NO 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 CLINIC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16629091 ↗
• MalfunctionFeb 15, 2023Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A DISCORDANT, NON-REPRODUCIBLE, LOWER THAN EXPECTED B-HCG RESULT WAS OBTAINED WHEN A PATIENT SAMPLE WAS TESTED USING VITROS B-HCG LOT 3630 ON A VITROS XT7600 INTEGRATED SYSTEM. PATIENT 1 RESULT OF 2.39 MIU/ML VERSUS THE EXPECTED RESULT OF 20218 MIU/ML BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE DISCORDANT, NON-REPRODUCIBLE, LOWER THAN EXPECTED VITROS B-HCG RESULT OF 2.39 MIU/ML FOR PATIENT 1 WAS 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) COMPLAINT NUMBER (B)(4) AND REPORTABILITY ASSESSMENT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16379747 ↗
• MalfunctionFeb 10, 2023Low Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED VITROS TOTAL B-HCG II (BHCG) RESULTS WERE OBTAINED FROM VITROS REPRODUCTIVE ENDOCRINOLOGY (RE) QUALITY CONTROLS USING VITROS IMMUNODIAGNOSTICS PRODUCTS TOTAL BHCG II REAGENT LOT 3580 IN COMBINATION WITH A VITROS ECI IMMUNODIAGNOSTIC SYSTEM. VITROS RE LOT 0830 LEVEL 1 RESULTS OF 3.48, 3.42, 3.44, 3.5, 3.67, 3.61, 3.46, 3.48, 3.56, 3.57, 3.52 AND 3.54 IU/L VS AN EXPECTED RESULT OF 11.06 IU/L 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 BHCG RESULTS WERE FROM NON-PATIENT FLUIDS. THE CUSTOMER DID NOT GIVE ANY INDICATION THAT PATIENT RESULTS HAD BEEN AFFECTED. THERE IS 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 16349311 ↗