Recall Z-0688-2019— ORTHO-CLINICAL DIAGNOSTICS

Class II FDA medical device recall by ORTHO-CLINICAL DIAGNOSTICS, initiated 2018-11-01. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: 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..

Recalling firm

ORTHO-CLINICAL DIAGNOSTICS

Classification

Class II

Status

Ongoing

Initiated

2018-11-01

Firm location

Bridgend, N/A, United Kingdom

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