Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
VITROS Chemistry Products PHYT Slides Recalled by Ortho-Clinical Diagnostics Due to The firm identified the potential for biased 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 Chemistry Products PHYT Slides, REF/CATALOG 829 8671, Rx ONLY, IVD; Ortho-Clinical Diagnostics, Inc. For in vitro diagnostic use only. VITROS Chemistry Products PHYT Slides quantitatively measure phenytoin (PHYT) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
Quantity: US; 4680; Foreign: 1286
Why Was This Recalled?
The firm identified the potential for biased results to be generated when processing VITROS PHYT Slide product with citrate plasma specimen samples. The current Instructions for Use (IFU) and Assay Summary Chart state serum, heparin plasma, and citrate plasma as acceptable specimen types for use with the PHYT assay.
Where Was This Sold?
Worldwide Distribution - US Distribution including Puerto Rico and the following countries: Bermuda, Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Republic of Panama, Poland, Singapore, Spain, Russia and Venezuela.
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