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Terminated

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.).

FDA Recall Z-2671-2014 · Posted 2014-09-19

Recalling FirmORTHO-CLINICAL DIAGNOSTICS
Recall StatusTerminated
Product CodeMZO
Date Initiated2014-08-06
Date Terminated2017-04-14
Product Quantity463 sales units

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).

Firm Action

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.

Root Cause

Packaging process control

Distribution Pattern

NY, NJ, CT, MA, PA, VA, MD, FL and GA

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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