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U.S. Department of Health and Human Services

Class 2 Device Recall VITROS Immunodiagnostic Products AntiHCV Reagent Pack

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  Class 2 Device Recall VITROS Immunodiagnostic Products AntiHCV Reagent Pack see related information
Date Initiated by Firm August 06, 2014
Date Posted September 19, 2014
Recall Status1 Terminated 3 on April 14, 2017
Recall Number Z-2671-2014
Recall Event ID 68974
PMA Number P010021S024 
Product Classification Assay,enzyme linked immunosorbent,hepatitis c virus - Product Code MZO
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.).
Code Information Lot 9090 (exp. December 15, 2014)
Recalling Firm/
Manufacturer		 ORTHO-CLINICAL DIAGNOSTICS
FELINDRE MEADOWS
Bridgend United Kingdom
For Additional Information Contact Jennifer Paine
908-218-8776
Manufacturer 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).
FDA Determined
Cause 2		 Packaging process control
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.
Quantity in Commerce 463 sales units
Distribution NY, NJ, CT, MA, PA, VA, MD, FL and GA
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA Database PMAs with Product Code = MZO and Original Applicant = Ortho-Clinical Diagnostics, Inc.
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