Diagnostic Equipment

The fixation of the upper and lower tilt actuator, of the MD-Eleva system might break off and the table will start to rotate from 0 to + 90 I- 90 degree with high speed. This rotating movement cannot be stopped by the user.

Potential for loss of activity of the glucose analyte (under-recovery) prior to the full stated shelf life (August 2018)

The software responsible for starting scheduled AutoQC measurements (scheduler) will not activate.

Potential failure of sterile packaging seal.

Potential failure of sterile packaging seal.

Upon dilution, some patient samples may exhibit over-recovery outside the representative data provided in the assay instructions for use.

The color coded French size indicator on the outer box may incorrectly reflect a 6 French size, rather than the correct 5 French size. The catheters inside the carton are the correct DXT5JL40 item, the inner pouch has correct 5F labeling, information and configuration details.

The kits may produce an elevated rate of false positive calls for the Staphylococcus aureus identification probe (SAU).

Potential failure of sterile packaging seal.

Potential failure of sterile packaging seal.

Potential failure of sterile packaging seal.

The previous version of method sheets for the Acetaminophen assay on the COBAS INTEGRA 400 plus/800/800 CTS analyzers and the MODULAR ANALYTICS P module are missing the following statement in the Limitations-interference section: "In very rare cases, gammopathy, in particular type IgM (Waldenstr¿m s macroglobulinemia), may cause unreliable results."

Potential failure of sterile packaging seal.

Potential failure of sterile packaging seal.

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.

Potential failure of sterile packaging seal.

Potential failure of sterile packaging seal.

Potential failure of sterile packaging seal.

Potential failure of sterile packaging seal.

Inaccurrate flow readings. Depending on the degree of inaccuracy, this issue may not be easy for the user to detect during setup or use (for example, following a Flow Probe relocation or manipulation).