Other Medical Devices

Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch

Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch

Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch

Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch

Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch

Disposable face masks labeled as non-medical were distributed to customers expecting medical use face masks.

Roche has confirmed customer complaints of low quality (QC) recovery and invalid calibrations for the identified products. A discoloration (yellow color) was observed and is the result of cross contamination between the R1 and R3 reagents.

Due to the potential for fluid ingress into the Arm which could affect the device's electrical system and lead to a failure of the locking mechanism

Roche has confirmed customer complaints of low quality (QC) recovery and invalid calibrations for the identified products. A discoloration (yellow color) was observed and is the result of cross contamination between the R1 and R3 reagents.

The firm has identified lots of calibrators that have shown to measure incorrect high values over time compared to the assigned values when released for distribution. This could result in higher Cystatin C values measured in patients.

Incorrectly crimped connectors were installed on the main protective earth conductor on these machines. If the machine is moved or maintenance is performed, these crimp connections could become loose and may adversely affect the electrical safety of the products, potentially resulting in electrical shock to the Biomed Technician or clinic staff.

There is a discrepancy between the printing on the Product Tyvek label of the individual component packaging. The Chinese characters on the label indicates that it contains an Equilibration Medium (P/N: 12220001) rather than the Vitrification Medium (P/N: 12230001) as indicated on the remainder of the label.

Intermittent failure of a signal being sent to a monitor from the touch panel display causing the displaying monitor to go Blank and the touch panel to display a Blank image when reviewing the target display. If this issue were to happen during a case, cause increase risk to patient due to hospital losing the visual image.

Product not properly being aligned with the adequate gamma sterilization group and result in the product not being properly sterilized

The buckle on the Gait Belt may break due to degradation of the material due to exposure to gamma radiation.

VGDF (VGA) Faceplate failure results in failure of video signal for SkyVision Linx 300, a secondary display. Video would continue on the primary source device display

Hex of the BellaTek Encode Definitive Abutments was misaligned by 30 degrees during manufacturing as compared with the provided patient scan data (Images may cause misalignment, the definitive abutment will not seat in the correct orientation upon attempted placement with the patient

Product not properly being aligned with the adequate gamma sterilization group and result in the product not being properly sterilized

Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilization capabilities.

Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilization capabilities.