Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
VITROS Immunodiagnostic VITROS Folate Reagent Pack 1/2 Recalled by Ortho-Clinical Diagnostics, Inc. Due to It was confirmed that fibrinogen in patient plasma...
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, Inc. directly.
Affected Products
VITROS Immunodiagnostic VITROS Folate Reagent Pack 1/2
Quantity: 18,467 units
Why Was This Recalled?
It was confirmed that fibrinogen in patient plasma samples precipitates out of solution upon the addition of folate stabilizer reagent as part of the pre-treatment process causing the increase in "TM5-4MB" condition codes which lead to a delay of results.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Ortho-Clinical Diagnostics, Inc.
Ortho-Clinical Diagnostics, Inc. has 62 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report