Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus
FDA adverse event reports and recall history for assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus (product code MZP), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 197
- Deaths
- 1
- Injuries
- 10
- Malfunctions
- 110
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2023-11-29Open, ClassifiedOther
Alinity m HCV AMP kit, List (REF) Numbers: a) 08N50-095 and b) 08N50-090. The Alinity m HCV assay is an in vitro reverse transcription-polymerase chain reaction (RT-PCR) assay for use with the automated Alinity m System to detect and quantitate hepatitis C virus (HCV) RNA in human serum or plasma.
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.
- 2011-06-17TerminatedOther
COBAS AmpliPrep / COBAS TaqMan HCV Test, US-IVD The COBAS AmpliPrep/COBAS TaqMan HCV Test is an in vitro nucleic acid amplification test for the quantitation of Hepatitis C viral (HCV) RNA in human plasma or serum of HCV-infected individuals using the COBAS AmpliPrep Instrument for automated specimen processing and the COBAS TaqMan Analyzer or the COBAS TaqMan 48 Analyzer for automated amplification and detection. Specimens containing HCV genotypes 1 6 have been validated for quantitation in the assay. The COBAS AmpliPrep/COBAS TaqMan HCV Test is intended for use as an aid in the management of HCV-infected individuals undergoing anti-viral therapy. The assay measures HCV RNA levels at baseline and during treatment and can be utilized to predict sustained and non-sustained virological response to HCV therapy.
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.
- 2011-06-17TerminatedOther
COBAS AmpliPrep / COBAS TaqMan HCV Test, CE-IVD The COBAS AmpliPrep/COBAS TaqMan HCV Test is an in vitro nucleic acid amplification test for the quantitation of Hepatitis C Virus (HCV) RNA in human plasma or serum using the COBAS AmpliPrep Instrument for automated specimen processing and the COBAS TaqMan Analyzer or the COBAS TaqMan 48 Analyzer for automated amplification and detection. The Test is intended for use in conjunction with clinical presentation and other laboratory markers of HCV infection for the clinical management of patients with chronic HCV.
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.
- 2007-08-02TerminatedOther
Amplilink Software Versions 1.1, 1.3, 1.4, 2.41 COBAS AmpliPrep/COBAS Amplicor HCV Test, version 2.0
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.
- 2004-08-19TerminatedOther
Amplicor [3] AV-HRP. (Avidin-HRP (Horseradish Peroxidase) BGG Conjugate.) Kit: Amplicor HCV Detection Kit, v2.0
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.
- 2004-08-19TerminatedOther
Amplicor [3] AV-HRP, Avidin-HRP (Horseradish Peroxidase) BGG Conjugate. Kit: AmpliCap HCV MonitorTest, Export, RUO.
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.
- Open, ClassifiedUnder Investigation by firm
Alinity m System, Part No. 08N53-002
There is a potential for abnormal (non-sigmoidal) amplification curves.
- Open, ClassifiedSoftware design
Alinity m System, Part No. 08N53-002
There is a software issue associated with the ability to properly complete a Field Service Engineer Maintenance and Diagnostics procedure.
- Open, ClassifiedSoftware design
Alinity m System, Part No. 08N53-002
There is a software defect that can cause the Amplification Detection clamp CLEAN position to be set too high.
- TerminatedSoftware design
Alinity m System, Part No. 08N53-002
There is an issue with the installation of updated camera firmware on the system.
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