Z-1399-2011

Abbott RealTime HBV Assay, List 2N40, in vitro diagnostic; Abbott Molecular Inc., Des Plaines, IL 60018 USA...

Name: Z-1399-2011 Abbott RealTime HBV Assay, List 2N40, in vitro diagnostic; Abbott Molecular Inc., Des Plaines, IL 60018 USA...
Creator: Abbott Molecular
Published: 2010-12-20
License: https://open.fda.gov/license/

Abbott Molecular, Inc. / initiated 2010-12-20 / Terminated / root cause: labeling and UDI

FDA source

Abbott Molecular began a recall of 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... on 2010-12-20. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1399-2011
Status: Terminated
Initiated: 2010-12-20
Posted: 2011-02-23
Terminated: 2012-11-19
Recalling firm: Abbott Molecular, Inc.
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.
Product code: MKT Hepatitis Viral B Dna Detection
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.
Root cause tag: labeling and UDI
FDA root cause: Other
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
Product codes and lots: All in date lots

Product code MKT

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)