FDAFDA · Food and drugs·Recall number Z-2671-2014
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.).
Published October 1, 2014 · Recall initiated: August 6, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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).
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- ORTHO-CLINICAL DIAGNOSTICS
- Distributor
- NY, NJ, CT, MA, PA, VA, MD, FL and GA
- Lot
- Lot 9090 (exp. December 15, 2014)
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United Kingdom
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