Recall Z-2671-2014— ORTHO-CLINICAL DIAGNOSTICS
Class II · Terminated
Class II FDA medical device recall by ORTHO-CLINICAL DIAGNOSTICS, initiated 2014-08-06, terminated 2017-04-14. FDA's recall record names no specific 510(k) clearance for this event. 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.).. Reason: 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)..
- Recalling firm
- ORTHO-CLINICAL DIAGNOSTICS
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-08-06
- Terminated
- 2017-04-14
- Firm location
- Bridgend, N/A, United Kingdom
Product description
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.).
Reason for recall
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).
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