VITROS 1612365Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10758750009398), received between Feb 12, 2026 and Feb 12, 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.

Recalls naming this device

1. Jul 13, 2020Terminated

   Etrombopag Interference for VITROS Chemistry Products: TBIL Slides, VITROS BuBc Slides and VITROS XT TBIL-ALKP Slides

   Z-2874-2020 · Root cause: Other · FDA record ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 12, 2026Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED UNCONJUGATED BILIRUBIN (BU) RESULTS WERE OBTAINED FROM A SINGLE LEVEL OF A NON-VITROS MAS QUALITY CONTROL (QC) FLUID USING VITROS CHEMISTRY PRODUCTS BU SLIDES LOT 0207-0486-4476 ON A VITROS XT 7600 INTEGRATED SYSTEM. MAS BILI LOT 2609 (LEVEL 3) RESULTS OF 6.61, 8.82, 8.35, 8.13, 8.49, 8.59, 8.34, 7.99, 7.92, 7.88, 7.92, 7.85, 7.72, 7.53, 7.60, 7.43, 7.53, 7.19, 7.16, AND 6.66 MG/DL VERSUS THE EXPECTED RESULT OF 12.06 MG/DL (MIDPOINT OF THE MAS PACKAGE INSERT RANGE) 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 BU RESULTS WERE FROM A NON-PATIENT FLUID AND WERE NOT REPORTED FROM THE LABORATORY. THE CUSTOMER CONFIRMED THERE HAVE BEEN NO COMPLAINTS FROM PHYSICIANS REGARDING PATIENT RESULTS. 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 24328120 ↗