Recalls for Assay, Hybridization And/or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,hepatitis C Virus

Abbott has received reports of an increase in reactive negative controls and false positive results in patient samples when using the Identified Lots of Alinity m HCV AMP Kit.

The COBAS Ampliprep/COBAS TaqMan HCV Test has been shown to under-quantitate a subset of genotype 4 patient specimens by approximately 1.0-1.5 log 10 in the absence of any sequence mismatches.

The COBAS Ampliprep/COBAS TaqMan HCV Test has been shown to under-quantitate a subset of genotype 4 patient specimens by approximately 1.0-1.5 log 10 in the absence of any sequence mismatches.

For select COBAS AMPLICOR Tests run on the COBAS AMPLICOR Analyzer in conjunction with AMPLILINK software, a discrepancy has been identified between the onboard working reagent stability information reported by AMPLILINK Software (versions 1.1, 1.3, 1.4 and 2.41) and the stability information provided in the test kit package inserts/method manual.

An increased frequency of 'blue foci' that potentially can cause elevated A450 background in microwell plate wells after the addition of conjugate reagent during PCR detection.

An increased frequency of 'blue foci' that potentially can cause elevated A450 background in microwell plate wells after the addition of conjugate reagent during PCR detection.

There is a potential for abnormal (non-sigmoidal) amplification curves.

There is a software issue associated with the ability to properly complete a Field Service Engineer Maintenance and Diagnostics procedure.

There is a software defect that can cause the Amplification Detection clamp CLEAN position to be set too high.

There is an issue with the installation of updated camera firmware on the system.

Incorrect optical calibration