Abbott RealTime HBV Assay, List 2N40, in vitro diagnostic; Abbott Molecular Inc., Des Plaines, IL 60018 USA The Abbott RealTime HBV is an in vitro polymerase chain reaction (PCR) assay for the quantitation of Hepatitis B Virus (HBV) DNA in human plasma or serum from HBV-infected individuals. The Abbott RealTime HBV assay is intended for use in conjunction with clinical presentation and other laboratory markers as an indicator of disease prognosis and for use as an aid in assessing viral response to antiviral treatment as measured by changes in plasma or serum HBV DNA levels. This assay is not intended for use as a screening test for HBV or as a diagnostic test to confirm the presence of HBV infection.
FDA Recall Z-1399-2011 · Posted 2011-02-23
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Recalling FirmAbbott Molecular
Recall StatusTerminated
Product CodeMKT
Date Initiated2010-12-20
Date Terminated2012-11-19
Reason for Recall
Internal testing identified the potential of under filled and over filled enzyme reagent vials which may result in obtaining less than the total number of tests per kit as described on the package insert.
Firm Action
Abbott Molecular sent a Field Advisory Notice letter to all RealTime HIV-1, CT/NG and HBV assay customers on December 20, 2010, informing them that internal testing identified the potential of under filled and over filled enzyme vials which may result in obtaining less than the total number of tests per kit as described in the package insert. The customers were told that specimens that meet acceptance criteria, per the product labeling are not affected by the situation and are considered valid results, and that the issue has no impact on results for those runs that generate valid results. Any questions were directed to Abbott Technical Support at 1-800-553-7042, Option 2.
Root Cause
Other
Distribution Pattern
Nationwide Distribution
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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