VITROS 8379034Recalls & reported problems

Summary

The FDA's MAUDE database contains 76 adverse event reports that list this exact device (DI 10758750004812), received between Feb 7, 2023 and Sep 11, 2026 — classified as 76 malfunctions.

The most frequently reported specific device problem is “High Test Results” (71 reports).

1 FDA recall record name this device's identifier.

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Recalls naming this device

1. May 5, 2018Terminated

   Potential for positively biased results

   Z-3280-2018 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 76 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 11, 2026Low Test Results; Non Reproducible Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50736852 ↗
• MalfunctionApr 30, 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 SODIUM (NA+) RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE PROCESSED USING VITROS CHEMISTRY PRODUCTS NA+ SLIDES LOT 4282-1162-3069 ON A VITROS XT 7600 INTEGRATED SYSTEM. PATIENT SAMPLE RESULT OF >250 MMOL/L VS AN EXPECTED RESULT OF 128.0 MMOL/L 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 RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THERE HAVE BEEN 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 25045814 ↗
• MalfunctionApr 9, 2026High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A HIGHER THAN EXPECTED SODIUM RESULT OBTAINED FROM A NON-VITROS BIORAD QUALITY CONTROL FLUID PROCESSED USING VITROS CHEMISTRY PRODUCTS SODIUM (NA+) SLIDES LOT 4209-1181-8890 ON A VITROS 5600 INTEGRATED SYSTEM. BIORAD LOT 56770 L1 RESULT OF 142.8 MMOL/L VS AN EXPECTED RESULT OF 110.0 MMOL/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 THAN EXPECTED VITROS NA+ RESULT WAS OBTAINED FROM A QUALITY CONTROL FLUID AND WAS NOT REPORTED FROM THE LABORATORY. THERE HAVE BEEN 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 24833171 ↗
• MalfunctionApr 8, 2026High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED SODIUM RESULTS OBTAINED FROM A VITROS PERFORMANCE VERIFIER PROCESSED USING VITROS CHEMISTRY PRODUCTS SODIUM (NA+) SLIDES LOT 4203-1176- 6973 ON A VITROS 350 CHEMISTRY SYSTEM. VITROS PV I LOT G2905 RESULTS OF 138.7 AND 138.5 MMOL/L VS THE EXPECTED RESULT OF 116.4 MMOL/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-THAN-EXPECTED VITROS NA+ RESULTS WERE OBTAINED FROM A QUALITY CONTROL FLUID AND WERE NOT REPORTED FROM THE LABORATORY. THE CUSTOMER CONFIRMED THAT NO PATIENT SAMPLE RESULTS WERE AFFECTED. HOWEVER, THE INVESTIGATION CANNOT CONCLUDE THAT PATIENT SAMPLE RESULTS WOULD NOT BE AFFECTED IF THE EVENT WERE TO RECUR UNDETECTED. THERE HAVE BEEN NO ALLEGATIONS OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER TWO OF TWO 3500A FORMS 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 24815437 ↗
• MalfunctionApr 8, 2026High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED SODIUM RESULTS OBTAINED FROM A VITROS PERFORMANCE VERIFIER PROCESSED USING VITROS CHEMISTRY PRODUCTS SODIUM (NA+) SLIDES LOT 4203-1176- 6973 ON A VITROS 350 CHEMISTRY SYSTEM. VITROS PV I LOT G2905 RESULTS OF 138.7 AND 138.5 MMOL/L VS THE EXPECTED RESULT OF 116.4 MMOL/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-THAN-EXPECTED VITROS NA+ RESULTS WERE OBTAINED FROM A QUALITY CONTROL FLUID AND WERE NOT REPORTED FROM THE LABORATORY. THE CUSTOMER CONFIRMED THAT NO PATIENT SAMPLE RESULTS WERE AFFECTED. HOWEVER, THE INVESTIGATION CANNOT CONCLUDE THAT PATIENT SAMPLE RESULTS WOULD NOT BE AFFECTED IF THE EVENT WERE TO RECUR UNDETECTED. THERE HAVE BEEN NO ALLEGATIONS OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER ONE OF TWO 3500A FORMS 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 24815434 ↗
• MalfunctionMar 18, 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 SODIUM RESULT OBTAINED FROM A SINGLE PATIENT SAMPLE PROCESSED USING VITROS CHEMISTRY PRODUCTS SODIUM (NA+) SLIDES LOT 4202-1174-7452 ON A VITROS 4600 CHEMISTRY SYSTEM. PATIENT RESULT OF 189.8 MMOL/L VS AN EXPECTED (REPEAT) RESULT OF 128.5 MMOL/L 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 PATIENT RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THERE HAS BEEN 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 24627275 ↗
• MalfunctionMar 12, 2026High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED VITROS SODIUM (NA+) RESULTS WERE OBTAINED FROM A SINGLE PATIENT SAMPLE AND A SINGLE VITROS PERFORMANCE VERIFIER (PV) I FLUID TESTED ON VITROS XT 7600 INTEGRATED SYSTEM, COMPARED TO REPEAT TESTING FROM THE SAME PATIENT SAMPLE. PATIENT SAMPLE VITROS NA+ RESULT OF >250 MMOL/L VS. THE REPEAT RESULT OF 126.8 MMOL/L VITROS PV I LOT E2828 VITROS NA+ RESULT OF >250 MMOL/L VS. THE BASELINE MEAN RESULT OF 125.8 MMOL/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 NA+ PATIENT SAMPLE RESULT WAS NOT REPORTED FROM THE LABORATORY AND THERE WAS NO ALLEGATION OF 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 24580578 ↗
• MalfunctionMar 12, 2026High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED VITROS SODIUM (NA+) RESULTS WERE OBTAINED FROM A SINGLE PATIENT SAMPLE AND A SINGLE VITROS PERFORMANCE VERIFIER (PV) I FLUID TESTED ON VITROS XT 7600 INTEGRATED SYSTEM, COMPARED TO REPEAT TESTING FROM THE SAME PATIENT SAMPLE. PATIENT SAMPLE VITROS NA+ RESULT OF >250 MMOL/L VS. THE REPEAT RESULT OF 126.8 MMOL/L VITROS PV I LOT E2828 VITROS NA+ RESULT OF >250 MMOL/L VS. THE BASELINE MEAN RESULT OF 125.8 MMOL/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 NA+ PATIENT SAMPLE RESULT WAS NOT REPORTED FROM THE LABORATORY AND THERE WAS NO ALLEGATION OF 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 24579519 ↗
• MalfunctionMar 3, 2026High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED VITROS SODIUM (NA+) RESULTS WERE OBTAINED FROM A SINGLE LEVEL OF NON-VITROS BIORAD QUALITY CONTROL (QC) FLUID (LOT 89750) USING VITROS NA+ SLIDE LOT 4201-1173-6107 ON A VITROS 5600 INTEGRATED SYSTEM. BIORAD LEVEL 2 (LOT 89750) VITROS NA+ RESULTS OF 135.0, 139.4 MMOL/L VERSUS THE EXPECTED RESULT OF 128.5 MMOL/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-THAN-EXPECTED VITROS NA+ RESULTS WERE OBTAINED WHEN PROCESSING A NON-PATIENT CONTROL FLUID. NO RESULTS WERE REPORTED OUT OF THE LABORATORY. THE CUSTOMER CLAIMED THAT PATIENT RESULTS WERE NOT IMPACTED BY THIS ISSUE. THERE WERE NO ALLEGATIONS 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 24498770 ↗
• MalfunctionMar 3, 2026High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED VITROS SODIUM (NA+) RESULTS WERE OBTAINED FROM A SINGLE LEVEL OF NON-VITROS BIORAD QUALITY CONTROL (QC) FLUID (LOT 89750) USING VITROS NA+ SLIDE LOT 4201-1173-6107 ON A VITROS 5600 INTEGRATED SYSTEM. BIORAD LEVEL 2 (LOT 89750) VITROS NA+ RESULTS OF 135.0, 139.4 MMOL/L VERSUS THE EXPECTED RESULT OF 128.5 MMOL/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-THAN-EXPECTED VITROS NA+ RESULTS WERE OBTAINED WHEN PROCESSING A NON-PATIENT CONTROL FLUID. NO RESULTS WERE REPORTED OUT OF THE LABORATORY. THE CUSTOMER CLAIMED THAT PATIENT RESULTS WERE NOT IMPACTED BY THIS ISSUE. THERE WERE NO ALLEGATIONS 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 24498762 ↗
• MalfunctionFeb 13, 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 SODIUM (NA+) RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE PROCESSED USING VITROS CHEMISTRY PRODUCTS NA+ SLIDES LOT 4203-1176-6731 ON A VITROS XT 7600 INTEGRATED SYSTEM. PATIENT RESULT OF > 250.0 MMOL/L VS AN EXPECTED (REPEAT) RESULT OF 125.9 MMOL/L 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 PATIENT RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THERE HAS BEEN 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 613429.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24337793 ↗
• MalfunctionFeb 9, 2026High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A HIGHER THAN EXPECTED VITROS SODIUM (NA+) RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE TESTED ON VITROS 4600 CHEMISTRY SYSTEM, COMPARED TO REPEAT TESTING FROM THE SAME PATIENT SAMPLE. PATIENT SAMPLE VITROS NA+ RESULT OF >250 MMOL/L VS. THE REPEAT RESULT OF 120.0 MMOL/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 NA+ RESULT WAS NOT REPORTED FROM THE LABORATORY AND THERE WAS NO ALLEGATION OF 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 24293996 ↗
• MalfunctionJan 20, 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 SODIUM (NA+) RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE PROCESSED USING VITROS CHEMISTRY PRODUCTS NA+ SLIDES LOT 4283-1163-3395 ON A VITROS 5600 INTEGRATED SYSTEM. PATIENT SAMPLE RESULT OF 141.6 MMOL/L VS AN EXPECTED RESULT OF 119.0 MMOL/L 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 NA+ RESULT WAS NOT REPORTED OUT OF 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 400298497 AND REPORTABILITY ASSESSMENT 613155.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24123167 ↗
• MalfunctionDec 16, 2025High Test Results; High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED SODIUM (NA+) RESULTS WERE OBTAINED FROM A VITROS PERFORMANCE VERIFIER (PV) PROCESSED USING VITROS CHEMISTRY PRODUCTS NA+ SLIDES LOT 4280-1161-3070 ON A VITROS 350 CHEMISTRY SYSTEM. VITROS PV I LOT E2828 RESULTS OF 141.4 AND 135.1 MMOL/L VS THE EXPECTED RESULT OF 125.8 MMOL/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 THAN EXPECTED RESULTS WERE OBTAINED FROM A NON-PATIENT CONTROL FLUID AND WERE NOT REPORTED OUT OF THE LABORATORY. THE CUSTOMER INDICATED THAT PATIENT SAMPLES WERE AFFECTED, HOWEVER, NO NUMERICAL RESULTS WERE PROVIDED. THERE WERE NO REPORTS OF TREATMENT BEING INITIATED, ALTERED OR STOPPED BASED ON ANY BIASED VITROS NA+ RESULTS. THERE WAS NO REPORTED 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 NUMBERS (B)(4) AND REPO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23820588 ↗
• MalfunctionDec 16, 2025High Test Results; High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED SODIUM (NA+) RESULTS WERE OBTAINED FROM A VITROS PERFORMANCE VERIFIER (PV) PROCESSED USING VITROS CHEMISTRY PRODUCTS NA+ SLIDES LOT 4280-1161-3070 ON A VITROS 350 CHEMISTRY SYSTEM. VITROS PV I LOT E2828 RESULTS OF 141.4 AND 135.1 MMOL/L VS THE EXPECTED RESULT OF 125.8 MMOL/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-THAN-EXPECTED RESULTS WERE OBTAINED FROM A NON-PATIENT CONTROL FLUID AND WERE NOT REPORTED OUT OF THE LABORATORY. THE CUSTOMER INDICATED THAT PATIENT SAMPLES WERE AFFECTED, HOWEVER, NO NUMERICAL RESULTS WERE PROVIDED. THERE WERE NO REPORTS OF TREATMENT BEING INITIATED, ALTERED OR STOPPED BASED ON ANY BIASED VITROS NA+ RESULTS. THERE WAS NO REPORTED 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 NUMBERS (B)(4) AND REPO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23820567 ↗
• MalfunctionNov 19, 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 SODIUM (NA+) RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE PROCESSED USING VITROS CHEMISTRY PRODUCTS NA+ SLIDES LOT 4202-1174-7266 ON A VITROS XT 7600 INTEGRATED SYSTEM. PATIENT RESULT OF 140.9 MMOL/L VS AN EXPECTED RESULT OF 124.0 MMOL/L 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 PATIENT RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THERE HAS BEEN 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 23594595 ↗
• 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 NON-REPRODUCIBLE, HIGHER THAN EXPECTED SODIUM (NA+) RESULTS WERE OBTAINED FROM A NON-VITROS BIORAD QUALITY CONTROL FLUID PROCESSED USING VITROS CHEMISTRY PRODUCTS NA+ SLIDES LOT 4267-1147-8042 ON A VITROS 4600 CHEMISTRY SYSTEM. BIORAD LOT 92990 LEVEL 1 RESULTS OF >250 AND >250 MMOL/L VS AN EXPECTED RESULT OF 122.2 MMOL/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 NON-REPRODUCIBLE, HIGHER THAN EXPECTED RESULTS WERE FROM A NON-PATIENT CONTROL FLUID AND WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THE CUSTOMER CONFIRMED THAT NO PATIENT SAMPLE RESULTS HAD BEEN AFFECTED OR QUESTIONED. THERE HAS BEEN NO REPORTED 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 23574271 ↗
• 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 NON-REPRODUCIBLE, HIGHER THAN EXPECTED SODIUM (NA+) RESULTS WERE OBTAINED FROM A NON-VITROS BIORAD QUALITY CONTROL FLUID PROCESSED USING VITROS CHEMISTRY PRODUCTS NA+ SLIDES LOT 4267-1147-8042 ON A VITROS 4600 CHEMISTRY SYSTEM. BIORAD LOT 92990 LEVEL 1 RESULTS OF >250 AND >250 MMOL/L VS AN EXPECTED RESULT OF 122.2 MMOL/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 NON-REPRODUCIBLE, HIGHER THAN EXPECTED RESULTS WERE FROM A NON-PATIENT CONTROL FLUID AND WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THE CUSTOMER CONFIRMED THAT NO PATIENT SAMPLE RESULTS HAD BEEN AFFECTED OR QUESTIONED. THERE HAS BEEN NO REPORTED 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 23571999 ↗
• MalfunctionNov 13, 2025Low Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A LOWER-THAN-EXPECTED VITROS SODIUM (NA+) RESULT WAS OBTAINED FROM PROCESSING A SINGLE PATIENT SAMPLE USING VITROS NA+ SLIDE LOT 4288-1168-5223 ON A VITROS 350 CHEMISTRY SYSTEM. PATIENT SAMPLE 1 VITROS RESULT OF 134.0 MMOL/L VS. THE EXPECTED RESULT OF 152.0 MMOL/L BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE LOWER-THAN-EXPECTED RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE BUT WAS NOT RELEASED FROM THE LABORATORY. THE CUSTOMER CONFIRMED THAT THERE HAVE BEEN 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 23542405 ↗
• MalfunctionNov 12, 2025High Test Results; High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED SODIUM RESULTS WERE OBTAINED FROM A VITROS PERFORMANCE VERIFIER (PV) QUALITY CONTROL FLUID USING VITROS CHEMISTRY PRODUCTS SODIUM (NA+) SLIDES LOT: 4282-1162-3122 ON A VITROS 5600 INTEGRATED SYSTEM. VITROS PV I E2828 RESULTS OF 139.7, 138.8 AND 140.2 MMOL/L VS. THE EXPECTED RESULT OF 126.2 MMOL/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-THAN-EXPECTED VITROS NA+ RESULTS WERE OBTAINED FROM A QUALITY CONTROL FLUID AND NO RESULTS WERE 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).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23535304 ↗
• MalfunctionSep 12, 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 SODIUMN (NA+) RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE PROCESSED USING VITROS CHEMISTRY PRODUCTS NA+ SLIDES LOT 4267-1147-8042 ON A VITROS 5600 INTEGRATED SYSTEM. PATIENT RESULT OF >250 MMOL/L VS AN EXPECTED RESULT OF 128 MMOL/L 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 RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THERE HAS BEEN 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 23036775 ↗
• MalfunctionSep 10, 2025Low Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A LOWER-THAN-EXPECTED VITROS SODIUM (NA+) RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE TESTED ON VITROS 5600 INTEGRATED SYSTEM, COMPARED TO REPEAT TESTING FROM THE SAME PATIENT SAMPLE. PATIENT (B)(6) SAMPLE VITROS NA+ RESULT OF 108.0 MMOL/L VS. THE REPEAT RESULT OF 153.1 MMOL/L 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 NA+ RESULT WAS NOT REPORTED FROM THE LABORATORY AND THERE ALLEGATION OF 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 23015483 ↗
• MalfunctionAug 19, 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 SODIUM RESULT WAS OBTAINED FROM A NON-VITROS BIORAD QUALITY CONTROL PROCESSED USING VITROS CHEMISTRY PRODUCTS SODIUM (NA+) SLIDES LOT 4267-1147-8042 ON A VITROS 5600 INTEGRATED SYSTEM. BIORAD LOT 92990 L2 RESULT OF >250 MMOL/L VS AN EXPECTED RESULT OF 122.2 MMOL/L BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLE, THE NON-REPRODUCIBLE, HIGHER THAN EXPECTED RESULT WAS FROM A NON-PATIENT FLUID AND WAS NOT REPORTED OUTSIDE OF THE LABORATORY. HOWEVER, THE INVESTIGATION CANNOT CONCLUDE THAT PATIENT SAMPLES WOULD NOT BE AFFECTED IF THE EVENT WERE TO RECUR UNDETECTED. THERE HAS BEEN 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 611638.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22844106 ↗
• MalfunctionAug 13, 2025Low 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 NON-REPRODUCIBLE, LOWER THAN EXPECTED SODIUM RESULT WAS OBTAINED FROM A NON-VITROS BIORAD QUALITY CONTROL PROCESSED USING VITROS CHEMISTRY PRODUCTS SODIUM (NA+) SLIDES LOT 4284-1165-3527 ON A VITROS XT 7600 INTEGRATED SYSTEM. BIORAD LOT 92980 L2 RESULT OF <75 MMOL/L VS AN EXPECTED RESULT OF 158.9 MMOL/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 NON-REPRODUCIBLE, LOWER THAN EXPECTED RESULT WAS FROM A NON-PATIENT FLUID AND WAS NOT REPORTED OUTSIDE OF THE LABORATORY. HOWEVER, THE INVESTIGATION CANNOT CONCLUDE THAT PATIENT SAMPLES WOULD NOT BE AFFECTED IF THE EVENT WERE TO RECUR UNDETECTED. THERE HAS BEEN 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 22797960 ↗
• MalfunctionJul 29, 2025High Test Results; High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A HIGHER-THAN-EXPECTED VITROS NA+ RESULT WAS OBTAINED FROM A SINGLE LEVEL OF NON-VITROS THERMOFISHER MAS OMNICORE (MAS) CONTROL, LOT OCR2608, USING VITROS SODIUM (NA+) SLIDE LOT 4273-1155-1024 ON A VITROS 4600 CHEMISTRY SYSTEM. MAS L1 NA+ RESULT OF 136.6 MMOL/L VS. THE EXPECTED RESULT OF 121.1 MMOL/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-THAN-EXPECTED RESULTS WERE OBTAINED FROM NON-PATIENT SAMPLE QUALITY CONTROL SAMPLES. HOWEVER, THE INVESTIGATION COULD NOT RULE OUT THAT PATIENT SAMPLES WERE NOT OR WOULD NOT BE AFFECTED IF THE EVENT OCCURRED UNDETECTED. 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 22648115 ↗