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.).
Recall
- Recall Number
- Z-2671-2014
- Event Number
- 68974
- Firm
- ORTHO-CLINICAL DIAGNOSTICS FELINDRE MEADOWS Bridgend United Kingdom
- FEI Number
- 3007111389
- Product Code
- MZO
- Status
- Terminated
- Root Cause
- Packaging process control
- Initiated
- August 6, 2014
- Posted
- September 19, 2014
- Terminated
- April 14, 2017
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.).
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).
All US consignees (users) who were shipped the affected lot VITROS HCV Reagent Pack were sent communications via FedEx and/or US Priority Mail (PO Boxes only) on 8/06/14, and advised of the issue and to immediately discontinue using all remaining inventory of VITROS Anti-HCV Reagent Packs Lot 9090. For additional information, please contact OCD's Customer Technical Service representatives at 1-800-421-3311.
NY, NJ, CT, MA, PA, VA, MD, FL and GA
463 sales units