Torrent Suite Dx Software versions 5.14 and earlier used in connection with Ion PGM DX Systems exploitation of the vulnerability by a threat actor may allow them to alter settings, configurations, software, or data on the instrument
Life Technologies
23 recalls • • Categories: Surgical Instruments, Diagnostic Equipment, Infusion Pumps, Other Medical Devices
COVID-19 Interpretive Software issues that may cause: 1) the risk of invalid or inconclusive tests/false negative and potentially increasing the retesting burden on customers. 2) false positive results due to improper vortexing.
COVID-19 Interpretive Software issues that may cause: 1) the risk of invalid or inconclusive tests/false negative and potentially increasing the retesting burden on customers. 2) false positive results due to improper vortexing.
Class I - Dangerous
Extended Expiration Date prior to clearance
Class I - Dangerous
Extended Expiration Date prior to clearance
Class I - Dangerous
Extended Expiration Date prior to clearance
Class I - Dangerous
Extended Expiration Date prior to clearance
Class I - Dangerous
Component was not tested by the supplier for adventitious agents
Class I - Dangerous
Component was not tested by the supplier for adventitious agents
Class I - Dangerous
Leaky bottles due to a defect in the bottle cap compromising the sterility of the product
Class I - Dangerous
Leaky bottles due to a defect in the bottle cap compromising the sterility of the product
Class I - Dangerous
Leaky bottles due to a defect in the bottle cap compromising the sterility of the product
Class I - Dangerous
Leaky bottles due to a defect in the bottle cap compromising the sterility of the product
Class I - Dangerous
It has been determined that the fill port tube seal integrity was compromised during the manufacture of the product lot. This may cause media to leak out of the primary sterile packaging into outer non-sterile dust cover packaging, and subsequently mold may grow in the pooled, leaked media.
Class I - Dangerous
It has been determined that the fill port tube seal integrity was compromised during the manufacture of the product lot. This may cause media to leak out of the primary sterile packaging into outer non-sterile dust cover packaging, and subsequently mold may grow in the pooled, leaked media.
Class I - Dangerous
It has been determined that the fill port tube seal integrity was compromised during the manufacture of the product lot. This may cause media to leak out of the primary sterile packaging into outer non-sterile dust cover packaging, and subsequently mold may grow in the pooled, leaked media.
Class I - Dangerous
It has been determined that the fill port tube seal integrity was compromised during the manufacture of the product lot. This may cause media to leak out of the primary sterile packaging into outer non-sterile dust cover packaging, and subsequently mold may grow in the pooled, leaked media.
Class I - Dangerous
It has been determined that the fill port tube seal integrity was compromised during the manufacture of the product lot. This may cause media to leak out of the primary sterile packaging into outer non-sterile dust cover packaging, and subsequently mold may grow in the pooled, leaked media.
Class I - Dangerous
It has been determined that the fill port tube seal integrity was compromised during the manufacture of the product lot. This may cause media to leak out of the primary sterile packaging into outer non-sterile dust cover packaging, and subsequently mold may grow in the pooled, leaked media.
Class I - Dangerous
The lower concentration of the RNA panel could cause a NO CALL or FALSE NEGATIVE for the reporting of ROS1 fusion. If a physician relies on a false negative result, crizotinib could be improperly excluded from the patient's treatment regimen.
Class I - Dangerous
Three lots of Human Fetal Hemoglobin FITC Conjugate are displaying high background and unusual bright staining in the controls and patient samples which could potentially lead to erroneous results (i.e. false positives)
The Oncomine Dx Target Test may report erroneous results when used off-label for samples other than non-small cell lung cancer (NSCLC) tumor specimens.
Firm received complaints that HSV-2 primers failed to amplify HSV-2 DNA.