An instrument intended for sequencing DNA libraries with in vitro diagnostic assays is used with reagent kits including flow cells that have flow cell gaskets that have a quality issue, which may lead to flow cell leaks during runs, which could cause run failures, that may result in: No/insufficient data output, instrument fluidics clogs, toxic substance exposure to user.
Illumina
9 recalls • • Categories: Diagnostic Equipment, Surgical Instruments, Other Medical Devices, Infusion Pumps
Class I - Dangerous
Cybersecurity vulnerability concerning the software used for sequencing instruments.
Class I - Dangerous
Cybersecurity vulnerability concerning the software used for sequencing instruments.
Class I - Dangerous
cybersecurity vulnerability
Class I - Dangerous
cybersecurity vulnerability
Class I - Dangerous
There is a potential that the DNA sequence analyzer may short circuit shortly after disconnection and reconnection of circuit board or imaging module due to an insufficient reconnection of the ribbon cable. The short circuit results in the device being inoperable.
It was discovered a software limitation with MiSeq Reporter software (version 2.2.31) when using the MiSeqDx Universal Kit 1.0 on the MiSeqDx instrument. The software cannot report insertions or deletions at specific genomic locations with respect to the primer.
Class I - Dangerous
Illumina has confirmed a software limitation with MiSeq Reporter software (version 2.2.31) when using the MiSeqDx Cystic Fibrosis Clinical Sequencing Assay on the MiSeqDx instrument.
A software component of the MiSeqDx instrument, called the Illumina Worklist Manager (IWM) v1.0.15, fails to perform as intended