Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
VITROS 250 Chemistry System Recalled by Ortho-Clinical Diagnostics Due to Potential negative drift in Creatine Kinase (CK) results...
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 250 Chemistry System, Product Code 8132086, (UDI # 10758750004409) Product Usage: Performs discrete clinical tests on serum, urine, and cerebral spinal fluid specimens. Methodologies include colorimetric (CM), potentiometric (PM), rate (RT), and immuno-rate (IR) tests using multi-layered VITROS Slides.
Quantity: 5020 units
Why Was This Recalled?
Potential negative drift in Creatine Kinase (CK) results when used on the VITROS 250 and 350 Systems.
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