VITROS 6801059Recalls & reported problems
Ortho-Clinical Diagnostics, Inc. · VITROS ECI IMMUNODIAGNOSTIC SYSTEM - Refurbished · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10758750001040), received between Feb 17, 2026 and Feb 17, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Low Test Results” (1 report).
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Recalls naming this device
- Feb 20, 2019Terminated
Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS Systems
Z-1293-2019 · Root cause: Software design · FDA record ↗
Most reported problems
Device problems
- Low Test Results1
- Non Reproducible Results1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 17, 2026Low 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 B-HCG RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE WHEN USING VITROS IMMUNODIAGNOSTICS PRODUCT B-HCG II REAGENT LOT 4570 ON A VITROS ECIQ SYSTEM. THE RESULT WAS CONSIDERED DISCORDANT WHEN COMPARED TO REPEAT RESULTS OBTAINED FROM THE SAME PATIENT SAMPLE. PATIENT 1 VITROS B-HCG II RESULT OF <2.39 MIU/ML VS. THE EXPECTED RESULT OF 57.000 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 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 613405.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24371204 ↗
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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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