VITROS 8343386Recalls & reported problems
Ortho-Clinical Diagnostics, Inc. · VITROS Chemistry Products DGXN Slides · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
These are VITROS DGXN slides, reagent slides used on Ortho-Clinical Diagnostics VITROS analyzers to measure digoxin, a heart medication, in blood. Most of the 46 reports describe digoxin results coming out lower than expected, with one describing a higher-than-expected result; no deaths and no injuries were reported. Two open recalls, both from December 2024, say hemoglobin at lower-than-claimed concentrations can interfere and push digoxin results low. Reports fell sharply, from 17 in the prior 12 months to 1 in the last 12 months.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 46
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 46 adverse event reports that list this exact device (DI 10758750004782), received between May 9, 2023 and Dec 16, 2025 — classified as 46 malfunctions.
The most frequently reported specific device problem is “Low Test Results” (45 reports).
2 FDA recall records name this device's identifier, 2 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.
Reports received per month
Recalls naming this device
- Dec 5, 2024Open, Classified
Hemoglobin interference may occur at concentrations lower than the claimed 300 mg/dL, and may cause negatively biased digoxin results.
Z-0901-2025 · Root cause: Device Design · FDA record ↗
- Dec 5, 2024Open, Classified
Hemoglobin interference may occur at concentrations lower than the claimed 300 mg/dL, and may cause negatively biased digoxin results.
Z-0902-2025 · Root cause: Device Design · FDA record ↗
Most reported problems
Device problems
- Low Test Results45
- High Test Results1
Patient problems
- No Clinical Signs, Symptoms or Conditions46
Recent adverse event reports
The 25 most recent of 46 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 16, 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 DIGOXIN (DGXN) RESULT WAS OBTAINED WHEN PERFORMING A PATIENT CORRELATION STUDY USING VITROS DGXN LOT 1937-0275-8241 ON A VITROS 5600 INTEGRATED SYSTEM. VITROS DGXN PATIENT 5 RESULT OF 1.50 NMOL/L VERSUS THE EXPECTED RESULT OF 0.59 NMOL/L BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE VITROS DGXN RESULT WAS OBTAINED DURING A PATIENT CORRELATION AND WAS NOT REPORTED OUT OF 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 23820647 ↗MalfunctionMar 18, 2025Low Test Results; Low Test Results
A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED VITROS DIGOXIN (DGXN) RESULTS WERE OBTAINED FROM A NON-VITROS BIORAD QUALITY CONTROL PROCESSED USING VITROS CHEMISTRY PRODUCTS DGXN SLIDES LOT 1935-0272-7462 ON A VITROS 5600 INTEGRATED SYSTEM. BIORAD LOT 85350 LEVEL 3 RESULTS OF 1.97, 1.42, 1.41, 1.91, 1.92, 1.95, 2.01, 1.98, 1.86, 2.01, 1.64, 2.01, 1.92, 2.00, 1.52, 1.58 AND 1.80 NMOL/L VS. THE EXPECTED RESULT OF 2.688 NMOL/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 RESULTS WERE FROM A NON-PATIENT QUALITY CONTROL FLUID AND WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THERE HAVE BEEN NO REPORTED ALLEGATIONS OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER TWELVE OF SEVENTEEN MDRS FOR THIS EVENT. SEVENTEEN 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS SEVENTEEN 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 21632130 ↗MalfunctionMar 18, 2025Low Test Results; Low Test Results
A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED VITROS DIGOXIN (DGXN) RESULTS WERE OBTAINED FROM A NON-VITROS BIORAD QUALITY CONTROL PROCESSED USING VITROS CHEMISTRY PRODUCTS DGXN SLIDES LOT 1935-0272-7462 ON A VITROS 5600 INTEGRATED SYSTEM. BIORAD LOT 85350 LEVEL 3 RESULTS OF 1.97, 1.42, 1.41, 1.91, 1.92, 1.95, 2.01, 1.98, 1.86, 2.01, 1.64, 2.01, 1.92, 2.00, 1.52, 1.58 AND 1.80 NMOL/L VS. THE EXPECTED RESULT OF 2.688 NMOL/L BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LED TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. THE LOWER-THAN-EXPECTED RESULTS WERE FROM A NON-PATIENT QUALITY CONTROL FLUID AND WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THERE HAVE BEEN NO REPORTED ALLEGATIONS OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER FIFTEEN OF SEVENTEEN MDRS FOR THIS EVENT. SEVENTEEN 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS SEVENTEEN 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 21630814 ↗MalfunctionMar 18, 2025Low Test Results; Low Test Results
A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED VITROS DIGOXIN (DGXN) RESULTS WERE OBTAINED FROM A NON-VITROS BIORAD QUALITY CONTROL PROCESSED USING VITROS CHEMISTRY PRODUCTS DGXN SLIDES LOT 1935-0272-7462 ON A VITROS 5600 INTEGRATED SYSTEM. BIORAD LOT 85350 LEVEL 3 RESULTS OF 1.97, 1.42, 1.41, 1.91, 1.92, 1.95, 2.01, 1.98, 1.86, 2.01, 1.64, 2.01, 1.92, 2.00, 1.52, 1.58 AND 1.80 NMOL/L VS. THE EXPECTED RESULT OF 2.688 NMOL/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 RESULTS WERE FROM A NON-PATIENT QUALITY CONTROL FLUID AND WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THERE HAVE BEEN NO REPORTED ALLEGATIONS OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER SIXTEEN OF SEVENTEEN MDRS FOR THIS EVENT. SEVENTEEN 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS SEVENTEEN 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 21630797 ↗MalfunctionMar 18, 2025Low Test Results; Low Test Results
A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED VITROS DIGOXIN (DGXN) RESULTS WERE OBTAINED FROM A NON-VITROS BIORAD QUALITY CONTROL PROCESSED USING VITROS CHEMISTRY PRODUCTS DGXN SLIDES LOT 1935-0272-7462 ON A VITROS 5600 INTEGRATED SYSTEM. BIORAD LOT 85350 LEVEL 3 RESULTS OF 1.97, 1.42, 1.41, 1.91, 1.92, 1.95, 2.01, 1.98, 1.86, 2.01, 1.64, 2.01, 1.92, 2.00, 1.52, 1.58 AND 1.80 NMOL/L VS. THE EXPECTED RESULT OF 2.688 NMOL/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 RESULTS WERE FROM A NON-PATIENT QUALITY CONTROL FLUID AND WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THERE HAVE BEEN NO REPORTED ALLEGATIONS OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER FOURTEEN OF SEVENTEEN MDRS FOR THIS EVENT. SEVENTEEN 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS SEVENTEEN 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 21630777 ↗MalfunctionMar 18, 2025Low Test Results; Low Test Results
A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED VITROS DIGOXIN (DGXN) RESULTS WERE OBTAINED FROM A NON-VITROS BIORAD QUALITY CONTROL PROCESSED USING VITROS CHEMISTRY PRODUCTS DGXN SLIDES LOT 1935-0272-7462 ON A VITROS 5600 INTEGRATED SYSTEM. BIORAD LOT 85350 LEVEL 3 RESULTS OF 1.97, 1.42, 1.41, 1.91, 1.92, 1.95, 2.01, 1.98, 1.86, 2.01, 1.64, 2.01, 1.92, 2.00, 1.52, 1.58 AND 1.80 NMOL/L VS. THE EXPECTED RESULT OF 2.688 NMOL/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 RESULTS WERE FROM A NON-PATIENT QUALITY CONTROL FLUID AND WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THERE HAVE BEEN NO REPORTED ALLEGATIONS OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER SEVENTEEN OF SEVENTEEN MDRS FOR THIS EVENT. SEVENTEEN 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS SEVENTEEN 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 21630766 ↗MalfunctionMar 18, 2025Low Test Results; Low Test Results
A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED VITROS DIGOXIN (DGXN) RESULTS WERE OBTAINED FROM A NON-VITROS BIORAD QUALITY CONTROL PROCESSED USING VITROS CHEMISTRY PRODUCTS DGXN SLIDES LOT 1935-0272-7462 ON A VITROS 5600 INTEGRATED SYSTEM. BIORAD LOT 85350 LEVEL 3 RESULTS OF 1.97, 1.42, 1.41, 1.91, 1.92, 1.95, 2.01, 1.98, 1.86, 2.01, 1.64, 2.01, 1.92, 2.00, 1.52, 1.58 AND 1.80 NMOL/L VS. THE EXPECTED RESULT OF 2.688 NMOL/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 RESULTS WERE FROM A NON-PATIENT QUALITY CONTROL FLUID AND WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THERE HAVE BEEN NO REPORTED ALLEGATIONS OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER THIRTEEN OF SEVENTEEN MDRS FOR THIS EVENT. SEVENTEEN 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS SEVENTEEN 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 21630757 ↗MalfunctionMar 18, 2025Low Test Results; Low Test Results
A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED VITROS DIGOXIN (DGXN) RESULTS WERE OBTAINED FROM A NON-VITROS BIORAD QUALITY CONTROL PROCESSED USING VITROS CHEMISTRY PRODUCTS DGXN SLIDES LOT 1935-0272-7462 ON A VITROS 5600 INTEGRATED SYSTEM. BIORAD LOT 85350 LEVEL 3 RESULTS OF 1.97, 1.42, 1.41, 1.91, 1.92, 1.95, 2.01, 1.98, 1.86, 2.01, 1.64, 2.01, 1.92, 2.00, 1.52, 1.58 AND 1.80 NMOL/L VS. THE EXPECTED RESULT OF 2.688 NMOL/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 RESULTS WERE FROM A NON-PATIENT QUALITY CONTROL FLUID AND WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THERE HAVE BEEN NO REPORTED ALLEGATIONS OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER TEN OF SEVENTEEN MDRS FOR THIS EVENT. SEVENTEEN 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS SEVENTEEN 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 21630746 ↗MalfunctionMar 18, 2025Low Test Results; Low Test Results
A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED VITROS DIGOXIN (DGXN) RESULTS WERE OBTAINED FROM A NON-VITROS BIORAD QUALITY CONTROL PROCESSED USING VITROS CHEMISTRY PRODUCTS DGXN SLIDES LOT 1935-0272-7462 ON A VITROS 5600 INTEGRATED SYSTEM. BIORAD LOT 85350 LEVEL 3 RESULTS OF 1.97, 1.42, 1.41, 1.91, 1.92, 1.95, 2.01, 1.98, 1.86, 2.01, 1.64, 2.01, 1.92, 2.00, 1.52, 1.58 AND 1.80 NMOL/L VS. THE EXPECTED RESULT OF 2.688 NMOL/L BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LED TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. THE LOWER-THAN-EXPECTED RESULTS WERE FROM A NON-PATIENT QUALITY CONTROL FLUID AND WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THERE HAVE BEEN NO REPORTED ALLEGATIONS OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER EIGHT OF SEVENTEEN MDRS FOR THIS EVENT. SEVENTEEN 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS SEVENTEEN 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 21630742 ↗MalfunctionMar 18, 2025Low Test Results; Low Test Results
A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED VITROS DIGOXIN (DGXN) RESULTS WERE OBTAINED FROM A NON-VITROS BIORAD QUALITY CONTROL PROCESSED USING VITROS CHEMISTRY PRODUCTS DGXN SLIDES LOT 1935-0272-7462 ON A VITROS 5600 INTEGRATED SYSTEM. BIORAD LOT 85350 LEVEL 3 RESULTS OF 1.97, 1.42, 1.41, 1.91, 1.92, 1.95, 2.01, 1.98, 1.86, 2.01, 1.64, 2.01, 1.92, 2.00, 1.52, 1.58 AND 1.80 NMOL/L VS. THE EXPECTED RESULT OF 2.688 NMOL/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 RESULTS WERE FROM A NON-PATIENT QUALITY CONTROL FLUID AND WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THERE HAVE BEEN NO REPORTED ALLEGATIONS OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER NINE OF SEVENTEEN MDRS FOR THIS EVENT. SEVENTEEN 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS SEVENTEEN 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 21630724 ↗MalfunctionMar 18, 2025Low Test Results; Low Test Results
A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED VITROS DIGOXIN (DGXN) RESULTS WERE OBTAINED FROM A NON-VITROS BIORAD QUALITY CONTROL PROCESSED USING VITROS CHEMISTRY PRODUCTS DGXN SLIDES LOT 1935-0272-7462 ON A VITROS 5600 INTEGRATED SYSTEM. BIORAD LOT 85350 LEVEL 3 RESULTS OF 1.97, 1.42, 1.41, 1.91, 1.92, 1.95, 2.01, 1.98, 1.86, 2.01, 1.64, 2.01, 1.92, 2.00, 1.52, 1.58 AND 1.80 NMOL/L VS. THE EXPECTED RESULT OF 2.688 NMOL/L BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LED TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. THE LOWER-THAN-EXPECTED RESULTS WERE FROM A NON-PATIENT QUALITY CONTROL FLUID AND WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THERE HAVE BEEN NO REPORTED ALLEGATIONS OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER ELEVEN OF SEVENTEEN MDRS FOR THIS EVENT. SEVENTEEN 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS SEVENTEEN 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 21630721 ↗MalfunctionMar 18, 2025Low Test Results; Low Test Results
A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED VITROS DIGOXIN (DGXN) RESULTS WERE OBTAINED FROM A NON-VITROS BIORAD QUALITY CONTROL PROCESSED USING VITROS CHEMISTRY PRODUCTS DGXN SLIDES LOT 1935-0272-7462 ON A VITROS 5600 INTEGRATED SYSTEM. BIORAD LOT 85350 LEVEL 3 RESULTS OF 1.97, 1.42, 1.41, 1.91, 1.92, 1.95, 2.01, 1.98, 1.86, 2.01, 1.64, 2.01, 1.92, 2.00, 1.52, 1.58 AND 1.80 NMOL/L VS. THE EXPECTED RESULT OF 2.688 NMOL/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 RESULTS WERE FROM A NON-PATIENT QUALITY CONTROL FLUID AND WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THERE HAVE BEEN NO REPORTED ALLEGATIONS OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER SEVEN OF SEVENTEEN MDRS FOR THIS EVENT. SEVENTEEN 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS SEVENTEEN 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 21630454 ↗MalfunctionMar 18, 2025Low Test Results; Low Test Results
A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED VITROS DIGOXIN (DGXN) RESULTS WERE OBTAINED FROM A NON-VITROS BIORAD QUALITY CONTROL PROCESSED USING VITROS CHEMISTRY PRODUCTS DGXN SLIDES LOT 1935-0272-7462 ON A VITROS 5600 INTEGRATED SYSTEM. BIORAD LOT 85350 LEVEL 3 RESULTS OF 1.97, 1.42, 1.41, 1.91, 1.92, 1.95, 2.01, 1.98, 1.86, 2.01, 1.64, 2.01, 1.92, 2.00, 1.52, 1.58 AND 1.80 NMOL/L VS. THE EXPECTED RESULT OF 2.688 NMOL/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 RESULTS WERE FROM A NON-PATIENT QUALITY CONTROL FLUID AND WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THERE HAVE BEEN NO REPORTED ALLEGATIONS OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER SIX OF SEVENTEEN MDRS FOR THIS EVENT. SEVENTEEN 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS SEVENTEEN 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 21630449 ↗MalfunctionMar 18, 2025Low Test Results; Low Test Results
A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED VITROS DIGOXIN (DGXN) RESULTS WERE OBTAINED FROM A NON-VITROS BIORAD QUALITY CONTROL PROCESSED USING VITROS CHEMISTRY PRODUCTS DGXN SLIDES LOT 1935-0272-7462 ON A VITROS 5600 INTEGRATED SYSTEM. BIORAD LOT 85350 LEVEL 3 RESULTS OF 1.97, 1.42, 1.41, 1.91, 1.92, 1.95, 2.01, 1.98, 1.86, 2.01, 1.64, 2.01, 1.92, 2.00, 1.52, 1.58 AND 1.80 NMOL/L VS. THE EXPECTED RESULT OF 2.688 NMOL/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 RESULTS WERE FROM A NON-PATIENT QUALITY CONTROL FLUID AND WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THERE HAVE BEEN NO REPORTED ALLEGATIONS OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER FIVE OF SEVENTEEN MDRS FOR THIS EVENT. SEVENTEEN 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS SEVENTEEN 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 21630443 ↗MalfunctionMar 18, 2025Low Test Results; Low Test Results
A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED VITROS DIGOXIN (DGXN) RESULTS WERE OBTAINED FROM A NON-VITROS BIORAD QUALITY CONTROL PROCESSED USING VITROS CHEMISTRY PRODUCTS DGXN SLIDES LOT 1935-0272-7462 ON A VITROS 5600 INTEGRATED SYSTEM. BIORAD LOT 85350 LEVEL 3 RESULTS OF 1.97, 1.42, 1.41, 1.91, 1.92, 1.95, 2.01, 1.98, 1.86, 2.01, 1.64, 2.01, 1.92, 2.00, 1.52, 1.58 AND 1.80 NMOL/L VS. THE EXPECTED RESULT OF 2.688 NMOL/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 RESULTS WERE FROM A NON-PATIENT QUALITY CONTROL FLUID AND WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THERE HAVE BEEN NO REPORTED ALLEGATIONS OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER FOUR OF SEVENTEEN MDRS FOR THIS EVENT. SEVENTEEN 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS SEVENTEEN 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 21630418 ↗MalfunctionMar 18, 2025Low Test Results; Low Test Results
A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED VITROS DIGOXIN (DGXN) RESULTS WERE OBTAINED FROM A NON-VITROS BIORAD QUALITY CONTROL PROCESSED USING VITROS CHEMISTRY PRODUCTS DGXN SLIDES LOT 1935-0272-7462 ON A VITROS 5600 INTEGRATED SYSTEM. BIORAD LOT 85350 LEVEL 3 RESULTS OF 1.97, 1.42, 1.41, 1.91, 1.92, 1.95, 2.01, 1.98, 1.86, 2.01, 1.64, 2.01, 1.92, 2.00, 1.52, 1.58 AND 1.80 NMOL/L VS. THE EXPECTED RESULT OF 2.688 NMOL/L BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LED TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. THE LOWER-THAN-EXPECTED RESULTS WERE FROM A NON-PATIENT QUALITY CONTROL FLUID AND WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THERE HAVE BEEN NO REPORTED ALLEGATIONS OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER THREE OF SEVENTEEN MDRS FOR THIS EVENT. SEVENTEEN 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS SEVENTEEN 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 21630417 ↗MalfunctionMar 18, 2025Low Test Results; Low Test Results
A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED VITROS DIGOXIN (DGXN) RESULTS WERE OBTAINED FROM A NON-VITROS BIORAD QUALITY CONTROL PROCESSED USING VITROS CHEMISTRY PRODUCTS DGXN SLIDES LOT 1935-0272-7462 ON A VITROS 5600 INTEGRATED SYSTEM. BIORAD LOT 85350 LEVEL 3 RESULTS OF 1.97, 1.42, 1.41, 1.91, 1.92, 1.95, 2.01, 1.98, 1.86, 2.01, 1.64, 2.01, 1.92, 2.00, 1.52, 1.58 AND 1.80 NMOL/L VS. THE EXPECTED RESULT OF 2.688 NMOL/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 RESULTS WERE FROM A NON-PATIENT QUALITY CONTROL FLUID AND WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THERE HAVE BEEN NO REPORTED ALLEGATIONS OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER TWO OF SEVENTEEN MDRS FOR THIS EVENT. SEVENTEEN 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS SEVENTEEN 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 21630408 ↗MalfunctionMar 18, 2025Low Test Results; Low Test Results
A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED VITROS DIGOXIN (DGXN) RESULTS WERE OBTAINED FROM A NON-VITROS BIORAD QUALITY CONTROL PROCESSED USING VITROS CHEMISTRY PRODUCTS DGXN SLIDES LOT 1935-0272-7462 ON A VITROS 5600 INTEGRATED SYSTEM. BIORAD LOT 85350 LEVEL 3 RESULTS OF 1.97, 1.42, 1.41, 1.91, 1.92, 1.95, 2.01, 1.98, 1.86, 2.01, 1.64, 2.01, 1.92, 2.00, 1.52, 1.58 AND 1.80 NMOL/L VS. THE EXPECTED RESULT OF 2.688 NMOL/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 RESULTS WERE FROM A NON-PATIENT QUALITY CONTROL FLUID AND WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THERE HAVE BEEN NO REPORTED ALLEGATIONS OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER ONE OF SEVENTEEN MDRS FOR THIS EVENT. SEVENTEEN 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS SEVENTEEN 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 21630402 ↗MalfunctionMay 13, 2024Low Test Results; Low Test Results
A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A LOWER THAN EXPECTED VITROS DIGOXIN (DGXN) RESULT WAS OBTAINED FROM A SINGLE LEVEL OF NON-VITROS BIORAD CONTROL LOT 853620 USING VITROS DGXN SLIDE LOT 1933-0269-9252, TESTED ON A VITROS 5600 INTEGRATED SYSTEM. BIORAD LEVEL 3 DGXN RESULT OF 1.47 NG/ML VS. AN EXPECTED RESULT OF 3.00 NG/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 AFFECTED QUALITY CONTROL SAMPLE WAS A NON-PATIENT SAMPLE. THE CUSTOMER MADE NO INDICATION THAT PATIENT SAMPLE RESULTS WERE AFFECTED. 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 19304800 ↗MalfunctionDec 5, 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 DIGOXIN (DGXN) RESULT WAS OBTAINED FROM AN INSTITUTE FOR QUALITY MANAGEMENT IN HEALTHCARE (IQMH) PROFICIENCY SAMPLE WHEN PROCESSED USING VITROS DGXN MICROSLIDES ON A VITROS XT7600 INTEGRATED SYSTEM. IQMH SAMPLE (B)(6) RESULT OF 1.9 VERSUS MEAN 2.8 NG/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 RESULTS WERE OBTAINED FROM AN IQMH PROFICIENCY FLUID. ORTHO WAS NOT MADE AWARE OF ANY ERRONEOUS PATIENTS RESULTS OBTAINED OR 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) (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18268902 ↗MalfunctionNov 14, 2023Low Test Results; Low Test Results
A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED VITROS DIGOXIN (DGXN) AND PHENOBARBITAL (PHBR) RESULTS WERE OBTAINED FROM A SINGLE LEVEL OF NON-VITROS THERMOFISHER MAS OMNICORE (MAS) LOT OCR2406 USING VITROS DGXN SLIDE LOT 1932-0268-4412 AND VITROS PHBR SLIDE LOT 2509-0098-9932, TESTED ON A VITROS XT7600 SYSTEM. MAS LEVEL 3 DGXN RESULTS OF 1.49, 1.03, 1.00, 1.39, 1.38, 1.04, 1.22, 1.26, 0.96, 1.10, 1.37, 1.37, 1.48, 1.28, 1.23, 1.16, 1.04, 1.48, 1.36, 1.48, 1.05, 1.14 AND 1.40 NG/ML VS. AN EXPECTED RESULT OF 2.02 NG/ML. MAS LEVEL 3 PHBR RESULTS OF 44.2, 44.8, 43.9 AND 44.9 UG/ML VS. AN EXPECTED RESULT OF 56.88 UG/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 AFFECTED QUALITY CONTROL SAMPLE WAS A NON-PATIENT QUALITY CONTROL SAMPLE. THE CUSTOMER MADE NO INDICATION THAT PATIENT SAMPLE RESULTS WERE AFFECTED AND THERE WERE NO REPORTED ALLEGATIONS OF PATIENT HARM. THIS REPORT IS NUMBER THREE OF TWENTY SEVEN MDR¿S FOR THIS EVENT. TWENTY SEVEN 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS TWENTY SEVEN
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18133732 ↗MalfunctionNov 14, 2023Low Test Results; Low Test Results
A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED VITROS DIGOXIN (DGXN) AND PHENOBARBITAL (PHBR) RESULTS WERE OBTAINED FROM A SINGLE LEVEL OF NON-VITROS THERMOFISHER MAS OMNICORE (MAS) LOT OCR2406 USING VITROS DGXN SLIDE LOT 1932-0268-4412 AND VITROS PHBR SLIDE LOT 2509-0098-9932, TESTED ON A VITROS XT7600 SYSTEM. MAS LEVEL 3 DGXN RESULTS OF 1.49, 1.03, 1.00, 1.39, 1.38, 1.04, 1.22, 1.26, 0.96, 1.10, 1.37, 1.37, 1.48, 1.28, 1.23, 1.16, 1.04, 1.48, 1.36, 1.48, 1.05, 1.14 AND 1.40 NG/ML VS. AN EXPECTED RESULT OF 2.02 NG/ML. MAS LEVEL 3 PHBR RESULTS OF 44.2, 44.8, 43.9 AND 44.9 UG/ML VS. AN EXPECTED RESULT OF 56.88 UG/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 AFFECTED QUALITY CONTROL SAMPLE WAS A NON-PATIENT QUALITY CONTROL SAMPLE. THE CUSTOMER MADE NO INDICATION THAT PATIENT SAMPLE RESULTS WERE AFFECTED AND THERE WERE NO REPORTED ALLEGATIONS OF PATIENT HARM. THIS REPORT IS NUMBER FOUR OF TWENTY SEVEN MDR¿S FOR THIS EVENT. TWENTY SEVEN 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS TWENTY SEVEN D
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18133726 ↗MalfunctionNov 14, 2023Low Test Results; Low Test Results
A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED VITROS DIGOXIN (DGXN) AND PHENOBARBITAL (PHBR) RESULTS WERE OBTAINED FROM A SINGLE LEVEL OF NON-VITROS THERMOFISHER MAS OMNICORE (MAS) LOT OCR2406 USING VITROS DGXN SLIDE LOT 1932-0268-4412 AND VITROS PHBR SLIDE LOT 2509-0098-9932, TESTED ON A VITROS XT7600 SYSTEM. MAS LEVEL 3 DGXN RESULTS OF 1.49, 1.03, 1.00, 1.39, 1.38, 1.04, 1.22, 1.26, 0.96, 1.10, 1.37, 1.37, 1.48, 1.28, 1.23, 1.16, 1.04, 1.48, 1.36, 1.48, 1.05, 1.14 AND 1.40 NG/ML VS. AN EXPECTED RESULT OF 2.02 NG/ML. MAS LEVEL 3 PHBR RESULTS OF 44.2, 44.8, 43.9 AND 44.9 UG/ML VS. AN EXPECTED RESULT OF 56.88 UG/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 AFFECTED QUALITY CONTROL SAMPLE WAS A NON-PATIENT QUALITY CONTROL SAMPLE. THE CUSTOMER MADE NO INDICATION THAT PATIENT SAMPLE RESULTS WERE AFFECTED AND THERE WERE NO REPORTED ALLEGATIONS OF PATIENT HARM. THIS REPORT IS NUMBER FIVE OF TWENTY SEVEN MDR¿S FOR THIS EVENT. TWENTY SEVEN 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS TWENTY SEVEN D
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18133715 ↗MalfunctionNov 14, 2023Low Test Results; Low Test Results
A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED VITROS DIGOXIN (DGXN) AND PHENOBARBITAL (PHBR) RESULTS WERE OBTAINED FROM A SINGLE LEVEL OF NON-VITROS THERMOFISHER MAS OMNICORE (MAS) LOT OCR2406 USING VITROS DGXN SLIDE LOT 1932-0268-4412 AND VITROS PHBR SLIDE LOT 2509-0098-9932, TESTED ON A VITROS XT7600 SYSTEM. MAS LEVEL 3 DGXN RESULTS OF 1.49, 1.03, 1.00, 1.39, 1.38, 1.04, 1.22, 1.26, 0.96, 1.10, 1.37, 1.37, 1.48, 1.28, 1.23, 1.16, 1.04, 1.48, 1.36, 1.48, 1.05, 1.14 AND 1.40 NG/ML VS. AN EXPECTED RESULT OF 2.02 NG/ML. MAS LEVEL 3 PHBR RESULTS OF 44.2, 44.8, 43.9 AND 44.9 UG/ML VS. AN EXPECTED RESULT OF 56.88 UG/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 AFFECTED QUALITY CONTROL SAMPLE WAS A NON-PATIENT QUALITY CONTROL SAMPLE. THE CUSTOMER MADE NO INDICATION THAT PATIENT SAMPLE RESULTS WERE AFFECTED AND THERE WERE NO REPORTED ALLEGATIONS OF PATIENT HARM. THIS REPORT IS NUMBER ONE OF TWENTY SEVEN MDR¿S FOR THIS EVENT. TWENTY SEVEN 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS TWENTY SEVEN DE
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18133711 ↗MalfunctionNov 14, 2023Low Test Results; Low Test Results
A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED VITROS DIGOXIN (DGXN) AND PHENOBARBITAL (PHBR) RESULTS WERE OBTAINED FROM A SINGLE LEVEL OF NON-VITROS THERMOFISHER MAS OMNICORE (MAS) LOT OCR2406 USING VITROS DGXN SLIDE LOT 1932-0268-4412 AND VITROS PHBR SLIDE LOT 2509-0098-9932, TESTED ON A VITROS XT7600 SYSTEM. MAS LEVEL 3 DGXN RESULTS OF 1.49, 1.03, 1.00, 1.39, 1.38, 1.04, 1.22, 1.26, 0.96, 1.10, 1.37, 1.37, 1.48, 1.28, 1.23, 1.16, 1.04, 1.48, 1.36, 1.48, 1.05, 1.14 AND 1.40 NG/ML VS. AN EXPECTED RESULT OF 2.02 NG/ML. MAS LEVEL 3 PHBR RESULTS OF 44.2, 44.8, 43.9 AND 44.9 UG/ML VS. AN EXPECTED RESULT OF 56.88 UG/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 AFFECTED QUALITY CONTROL SAMPLE WAS A NON-PATIENT QUALITY CONTROL SAMPLE. THE CUSTOMER MADE NO INDICATION THAT PATIENT SAMPLE RESULTS WERE AFFECTED AND THERE WERE NO REPORTED ALLEGATIONS OF PATIENT HARM. THIS REPORT IS NUMBER TWO OF TWENTY SEVEN MDR¿S FOR THIS EVENT. TWENTY SEVEN 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS TWENTY SEVEN DE
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18133691 ↗
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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