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U.S. Department of Health and Human Services

Class 3 Device Recall Abbott RealTime HBV Assay

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 Class 3 Recall
Abbott RealTime HBV Assay
see related information
Date Posted February 23, 2011
Recall Status1 Terminated on November 19, 2012
Recall Number Z-1399-2011
Recall Event ID 57431
Premarket Approval
PMA Number
P080026
Product Classification Hepatitis Viral B Dna Detection - Product Code MKT
Product 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.
Code Information All in date lots
Recalling Firm/
Manufacturer
Abbott Molecular
1300 E Touhy Ave
Des Plaines, Illinois 60018-3315
Manufacturer 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.
FDA Determined
Cause 2
OTHER/UNDETERMINED: Pending
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.
Distribution Nationwide Distribution
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
PMA Database PMAs with Product Code = MKT and Applicant = ABBOTT MOLECULAR, INC.
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