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Surestrips Covid-19 Antigen Tests are not authorized for sale in Canada as they were re-packaged into single tests and re-labelled without authorization by the manufacturers listed on the label (i.e. Artron Laboratories Inc.).  Recall start date…

Mold was found in lot Y591676 of the product. Two species of mold were identified that could pose a potential health risk to users. Recall start date: May 3, 2022

The pagewriter tc30/50/70 cardiograph device could potentially fail to charge while plugged into the ac power outlet. This is due to a faulty mainboard. based on a supplier analysis, the faulty mainboard was caused by…

An end user site attempted to perform QC on a single test using multiple QC kits. The QC module was not designed to support testing of multiple QC kits for a single test, and it is required that all QC samples used to validate a test are contained in a…

The encrypted barcode data generates an error that prevents the analyzer from using the entire contents of the bottle. The user is required to replace the reagent container prematurely. On 4/25/22, the issue was identified through the trending of post…

Surestrips Rapid Response Covid-19 Antigen Rapid Test Device are not authorized for sale in Canada as they were re-packaged into single tests and re-labelled without authorization by the manufacturers listed on the label (i.e.…

After initiating testing by a third-party lab, it was discovered that the tested lots did not meet the astm d6319 standard for medical gloves. Initial testing was received on March 4, 2022 and communicated to the original manufacturer. Confirmatory third…

The recall activities are being conducted due to several temperature excursions on inbound shipment to Canada.  According, to the assessment by the manufacturer, Anteis S.A, no data is available for Belotero products after repeated freezing and…

Potential for blood leak to occur with the anti-reflux valve upon treatment completion. Recall start date: May 5, 2022.

The Carescape Central Station (CSCS) V2 can shut down due to a potential power supply component failure. This can lead to loss of patient monitoring at the central station. Patient monitoring at the bedside is not affected. Recall start date: May 10,…

During continuous post market surveillance, Draeger gathered information and market feedback indicating that there is a need to provide additional information in the instructions for use regarding the potential of the user to incorrectly position the…

During global post market surveillance activities cases have been reported that the sampling pump 6873493 shows a changing characteristic with increasing operating time, which can lead to the deactivation of the gas measurement during operation. The…

Manufacturer has received reports of events related to airway obstruction while using the impacted device. Not following the instructions for use (IFU) and over-inflating the cuff increases intra-cuff pressure, which can cause the silicone cuff to extend…

Dräger has become aware of one case in which an obstructed Breathing System Filter Safestar 55 was used on a patient during anesthesia. The patient reportedly became hypoxic and had to be reanimated. If an obstructed filter is used on a patient,…

Since Nov. 2020, Arjo has become aware of 2 customer complaints involving overheating of metal part of the device located underneath its frame. The part involved is referred to as the e-bay box. No adverse health consequences (including temporary or…