VITROS 8433880Recalls & reported problems
Ortho-Clinical Diagnostics, Inc. · VITROS Chemistry Products LAC Slides · Class 1
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10758750004911), received between Mar 7, 2024 and Mar 7, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “High Test Results” (1 report).
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
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 7, 2024High Test Results; High Test Results
A CUSTOMER CONTRACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A HIGHER THAN EXPECTED VITROS LAC RESULT WAS OBTAINED WHEN PROCESSING A NON-VITROS BIORAD QUALITY CONTROL FLUID ON A VITROS 4600 CHEMISTRY SYSTEM. BIORAD MULTIQUAL PREMIUM ASSAYED CONTROLS, LOT 86960, VITROS LAC RESULT OF 6.22 MMOL/L VERSUS THE BASELINE MEAN OF 4.80 MMOL/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 HIGHER THAN EXPECTED VITROS LAC RESULT WAS OBTAINED WHEN PROCESSING QUALITY CONTROL FLUIDS. THERE WAS NO ALLEGATION 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 18857183 ↗
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- Atellica CH Lactate_2 (Lac_2) 11532568Siemens Healthcare Diagnostics Inc. · ACID, LACTIC, ENZYMATIC METHOD6 reports
- Lactate Gen.2 3183700190Roche Diagnostics GmbH · ACID, LACTIC, ENZYMATIC METHOD5 reports
- ARCHITECT 9P18-21Abbott Laboratories · ACID, LACTIC, ENZYMATIC METHOD4 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.