Recall Z-1399-2011
Abbott Molecular · initiated December 20, 2010
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.
Codes / lots: All in date lots
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: Other
Action taken
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.
Details
- Recall number
- Z-1399-2011
- Initiated
- December 20, 2010
- Posted by FDA
- February 23, 2011
- Terminated
- November 19, 2012
- Product code
- MKT – Hepatitis Viral B Dna Detection
- Distribution
- Nationwide Distribution
- Recalling firm
- Abbott Molecular, Des Plaines, IL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1397-2011 | Abbott RealTime CT/NG Assay, List 8L07, in vitro diagnostic; Abbott Molecular Inc., Des…Internal testing identified the potential of under filled and over filled enzyme reagent vials which may… | 12/20/2010Terminated |
| Z-1398-2011 | Abbott RealTime HIV-1 Assay, List 6L18, in vitro diagnostic; Abbott Molecular Inc., Des…Internal testing identified the potential of under filled and over filled enzyme reagent vials which may… | 12/20/2010Terminated |