VITROS 6802221Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10758750002337), received between Jan 7, 2025 and Jun 26, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “High Test Results” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 26, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED THAT HIGHER THAN EXPECTED VITROS BHCG RESULTS WERE OBTAINED FROM A SINGLE LEVEL OF NON-VITROS BIORAD LIQUICHEK IMMUNOASSAY PLUS CONTROLS, LOT 1003900, WHEN USING VITROS BHCG REAGENT LOT 4600, ON A VITROS XT7600 SYSTEM. BIORAD L1 VITROS BHCG RESULTS OF 7.79, 7.54, 7.88, 8.12 AND 7.95 MIU/ML VS. THE BIORAD LOT 1003900 PACKAGE INSERT TARGET OF 4.59 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 HIGHER-THAN-EXPECTED VITROS BHCG RESULTS WERE OBTAINED FROM NON-PATIENT QUALITY CONTROL FLUIDS. THE CUSTOMER DID NOT PROCESS ANY PATIENT SAMPLES, SINCE THE BIORAD CONTROL RESULTS WERE OUTSIDE THE PI RANGES FOR THOSE FLUIDS. THERE WAS NO ALLEGATION OF HARM. THIS REPORT IS NUMBER THREE OF THREE 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS THREE 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 22338741 ↗
• MalfunctionJun 26, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED THAT HIGHER THAN EXPECTED VITROS BHCG RESULTS WERE OBTAINED FROM A SINGLE LEVEL OF NON-VITROS BIORAD LIQUICHEK IMMUNOASSAY PLUS CONTROLS, LOT 1003900, WHEN USING VITROS BHCG REAGENT LOT 4600, ON A VITROS XT7600 SYSTEM. BIORAD L1 VITROS BHCG RESULTS OF 7.79, 7.54, 7.88, 8.12 AND 7.95 MIU/ML VS. THE BIORAD LOT 1003900 PACKAGE INSERT TARGET OF 4.59 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 HIGHER THAN EXPECTED VITROS BHCG RESULTS WERE OBTAINED FROM NON-PATIENT QUALITY CONTROL FLUIDS. THE CUSTOMER DID NOT PROCESS ANY PATIENT SAMPLES, SINCE THE BIORAD CONTROL RESULTS WERE OUTSIDE THE PI RANGES FOR THOSE FLUIDS. THERE WAS NO ALLEGATION OF HARM. THIS REPORT IS NUMBER TWO OF THREE 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS THREE 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 22338720 ↗
• MalfunctionJun 26, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED THAT HIGHER THAN EXPECTED VITROS BHCG RESULTS WERE OBTAINED FROM A SINGLE LEVEL OF NON-VITROS BIORAD LIQUICHEK IMMUNOASSAY PLUS CONTROLS, LOT 1003900, WHEN USING VITROS BHCG REAGENT LOT 4600, ON A VITROS XT7600 SYSTEM. BIORAD L1 VITROS BHCG RESULTS OF 7.79, 7.54, 7.88, 8.12 AND 7.95 MIU/ML VS. THE BIORAD LOT 1003900 PACKAGE INSERT TARGET OF 4.59 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 HIGHER-THAN-EXPECTED VITROS BHCG RESULTS WERE OBTAINED FROM NON-PATIENT QUALITY CONTROL FLUIDS. THE CUSTOMER DID NOT PROCESS ANY PATIENT SAMPLES, SINCE THE BIORAD CONTROL RESULTS WERE OUTSIDE THE PI RANGES FOR THOSE FLUIDS. THERE WAS NO ALLEGATION OF HARM. THIS REPORT IS NUMBER ONE OF THREE 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS THREE 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 22338683 ↗
• MalfunctionJan 7, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED THAT A HIGHER-THAN-EXPECTED VITROS B-HCG II RESULT WAS OBTAINED FROM A SINGLE LEVEL OF NON-VITROS BIORAD LIQUICHEK IMMUNOASSAY PLUS CONTROL (LOT 85360) WHEN TESTED USING VITROS B-HCG II LOT 4280 ON A VITROS 5600 INTEGRATED SYSTEM. BIORAD LOT 85361 RESULT OF 11.091 MIU/ML VERSUS THE EXPECTED RESULT OF 5.908 MIU/ML BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THE RESULTS WERE TO RECUR UNDETECTED. THE HIGHER-THAN-EXPECTED VITROS B-HCG II RESULT WAS OBTAINED FROM A NON-PATIENT QUALITY CONTROL FLUID; HOWEVER, THE INVESTIGATION CANNOT CONCLUDE THAT PATIENT SAMPLE RESULTS WOULD NOT BE AFFECTED IF THE EVENT WERE TO RECUR UNDETECTED. THERE WERE NO ALLEGATIONS OF PATIENT HARM AS A RESULT OF THE EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER (B)(4) AND REPORTABILITY ASSESSMENT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21093743 ↗