Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
VITROS 4600 Chemistry System Recalled by Ortho-Clinical Diagnostics Due to Software anomaly may incorrectly extend the on-analyzer stability...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Ortho-Clinical Diagnostics directly.
Affected Products
VITROS 4600 Chemistry System, Version 3.3.1 & below For use in the in vitro quantitative measurement of a variety of analytes of clinical interest in certain biological fluids (depending on the analyte) such as serum, plasma, urine and cerebrospinal fluid.
Quantity: 728
Why Was This Recalled?
Software anomaly may incorrectly extend the on-analyzer stability time for a loaded VITROS Reagent.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Ortho-Clinical Diagnostics
Ortho-Clinical Diagnostics has 185 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report