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ORTHO-CLINICAL DIAGNOSTICS recalls VITROS Immunodiagnostic Products Anti-HCV Reagent Pack for in vitro qualitative detection of immunoglobulin G antibody t
Recalled October 1, 2014 · FDA recall Z-2671-2014 · ORTHO-CLINICAL DIAGNOSTICS
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). · FDA Class II
Units
463 sales units
Sold at
NY, NJ, CT, MA, PA, VA, MD, FL and GA
Description
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).
Product
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.).
Manufacturer(s)
ORTHO-CLINICAL DIAGNOSTICS
Made in
United Kingdom
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →