VITROS 8097990Recalls & reported problems
Ortho-Clinical Diagnostics, Inc. · VITROS Chemistry Products CRP Slides · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- 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 10758750004355), received between Mar 3, 2026 and Mar 3, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “High Test Results” (1 report).
1 FDA recall record name this device's identifier, 1 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
- Apr 14, 2025Open, Classified
Product was incorrectly assigned GEN 88 instead of GEN 83 on product carton, foil wrapper, and cartridge (cart) label.
Z-1876-2025 · Root cause: Process control · FDA record ↗
Most reported problems
Device problems
- High Test 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.
MalfunctionMar 3, 2026High Test Results
A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A HIGHER-THAN-EXPECTED C-REACTIVE PROTEIN (CRP) RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE PROCESSED DURING REAGENT LOT TO LOT CORRELATION TESTING USING VITROS CHEMISTRY PRODUCTS CRP SLIDE LOT 3748-1315-0558 ON A VITROS XT 7600 INTEGRATED SYSTEM. PATIENT RESULT OF 1.16 MG/DL VS AN EXPECTED RESULT OF 0.82 MG/DL BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE HIGHER-THAN-EXPECTED PATIENT RESULT WAS OBTAINED DURING A REAGENT LOT TO LOT CORRELATION TEST AND WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THERE HAS 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 24501342 ↗
Other C-REACTIVE PROTEIN, ANTIGEN, ANTISERUM, AND CONTROL devices
- CRP CP3826Randox Laboratories Limited · C-Reactive Protein, Antigen, Antiserum, And Control1 recall0 reports
- VITROS 1926740Ortho-Clinical Diagnostics, Inc. · C-REACTIVE PROTEIN, ANTIGEN, ANTISERUM, AND CONTROL1 recall0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.