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One client reported that HL7 files transferred to an outbound results interface (specific to one client) would sometimes contain more than one patient identifier, which could lead to results being assigned to the wrong patient in a third party system…

On 03/17/2022, a Stryker spine operator packaging non-sterile Yukon Straight Rods from finished goods inventory discovered a Yukon Straight Rod 120 mm (cat#7601-540120, lot# pcmw) with orange and white discoloration on the surface of the device.…

GE Healthcare has become aware of two potential issues where inaccurate distance and area measurements can be displayed. Recall start date: May 5, 2022

A recall was issued in connection to false negative results for the Anti-Lua control (Lu 1) from lot 3113160-00, because minimum antibody levels were not met. The two lots (3131020-00 and 3131030-00) produced to replace lot 3113160-00 have shown a…

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

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…

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…

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…