Class 2 Device Recall VITROS HBeAg Reagent

• Date Initiated by Firm: November 01, 2018
• Create Date: January 03, 2019
• Recall Status: Open, Classified
• Recall Number: Z-0688-2019
• Recall Event ID: 81682
• PMA Number: P090028
• Product Classification: Test, hepatitis b (b core, be antigen, be antibody, b core igm) - Product Code LOM
• Product: VITROS HBeAg Reagent, Cat. No 6801819; ; Product Usage:; For the in vitro qualitative detection of hepatitis B e antigen (HBeAg) in human adult and pediatric (2 to 21 years old) serum from individuals who have symptoms of hepatitis or who may be at risk for hepatitis B virus (HBV) infection using the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System. Test results, in conjunction with other serological and clinical information, may be used for the laboratory diagnosis of individuals with acute or chronic hepatitis B, or recovery from hepatitis B infection. The VITROS HBeAg test should not be used to test cord blood samples. Test performance characteristics have not been established in patients under the age of 2, or in populations of immunocompromised or immunosuppressed patients. This test has not been FDA licensed for the screening of blood, plasma and tissue donors.
• Code Information: All expired, in-date, and future lots released.
• Recalling Firm/ Manufacturer: ORTHO-CLINICAL DIAGNOSTICS; Felindre Meadows; Bridgend United Kingdom
• Manufacturer Reason for Recall: The firm is extending their previous July 2018 recall to include additional product codes. Biased results may occur for these additional products at biotin concentrations which are lower than indicated in the current Instructions for Use.
• FDA Determined Cause: Device Design
• Action: On November 1, 2018, a customer letter was sent via FedEx overnight courier and/ or ORTHO PLUS e-Communications and/ or US Postal Service Priority Mail to all customers who could process the affected products to inform them of the potential interference of biotin at levels lower than stated in the IFUs and that Ortho is in the process of revising the IFUs for the affected products. Ortho recommended customers follow normal laboratory procedures for troubleshooting of samples containing other assay interferences and it was acceptable to continue using the affected products. If you have questions, please contact Ortho Care Technical Solutions Center at 1-800-421-3311.
• Quantity in Commerce: 3725 units (100 tests/unit)
• Distribution: Worldwide Distribution - US Nationwide domestic distribution. International distribution to Australia, Belgium, Bermuda, Brazil, Canada, Chile, China, Colombia, Denmark, India, France, Japan, Germany, Italy, Mexico, Norway, Poland, Portugal, Russia, Singapore, Spain, Sweden, The Netherlands, and United Kingdom.
• 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• PMA Database: PMAs with Product Code = LOM and Original Applicant = Ortho-Clinical Diagnostics, Inc.