Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
VITROS Chemistry Products VALP Reagent Pack. For in vitro diagnostic Recalled by Ortho-Clinical Diagnostics Due to Negative bias results when using VITROS VALP Reagent,...
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 VALP Reagent Pack. For in vitro diagnostic use only. CATALOG #(s): 6801710 INTENDED USE: For in vitro diagnostic use only. VITROS Chemistry Products VALP Reagent is used on the VITROS 5,1 FS Chemistry System, the VITROS 4600 Chemistry System and the VITROS 5600 Integrated System to quantitatively measure valproic acid (VALP) concentration in human serum and plasma.
Quantity: 9014 Total (U.S. = 6798; OUS: U.S. = 2216)
Why Was This Recalled?
Negative bias results when using VITROS VALP Reagent, GEN 25.
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