Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
VITROS Immunodiagnostic Products Anti-HCV Reagent Pack for in vitro qualitative Recalled by ORTHO-CLINICAL DIAGNOSTICS Due to VITROS Immunodiagnostic Products Anti-HCV kit lot 9090 has...
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 Immunodiagnostic Products Anti-HCV Reagent Pack for in vitro qualitative detection of immunoglobulin G antibody to hepatitis C virus (anti-HCV) in human serum and plasma. REF 680 2454, IVD -- Ortho-Clinical Diagnostics High Wycombe UK. Note that one sales unit has 5 Reagent Packs contained within it. Each Reagent Pack can test for 100 samples (patient, Quality Control, etc.).
Quantity: 463 sales units
Why Was This Recalled?
VITROS Immunodiagnostic Products Anti-HCV kit lot 9090 has been observed producing sporadic lower than expected VITROS Anti-HCV test results due to an approximate signal loss of up to 66.2% which can result in unexpected negative test results being obtained for reactive sample fluids (quality control and patient samples).
Where Was This Sold?
This product was distributed to 9 states: CT, FL, GA, MD, MA, NJ, NY, PA, VA
About ORTHO-CLINICAL DIAGNOSTICS
ORTHO-CLINICAL DIAGNOSTICS has 14 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report