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.).
This recall has been terminated (originally issued September 19, 2014).
- Recall Initiated
- August 6, 2014
- Posted
- September 19, 2014
- Terminated
- April 14, 2017
- Recall Number
- Z-2671-2014
- Quantity
- 463 sales units
- Official Source
- View on FDA website ↗
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).
Distribution
NY, NJ, CT, MA, PA, VA, MD, FL and GA
Lot / Code Info
Lot 9090 (exp. December 15, 2014)
Root Cause
Packaging process control
Action Taken
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.