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Displaying 1 - 15 of 277 items.
Simplexa Covid-19 Direct
Customer complaints were received for disc leaks while running Simplexa Covid-19 Direct kit with assay definition version 2 (high spin & temp). Leakage was confirmed by retain testing on 1/6/22 with discs run on Covid-19 Direct assay definition…
RecallHealth product recall | 2023-02-09
Simplexa Covid-19 & Flu A/B Direct
Customer complaints were received for disc leaks while running Simplexa Covid-19 Direct kit with assay definition version 2 (high spin & temp). Leakage was confirmed by retain testing on 1/6/22 with discs run on Covid-19 Direct assay definition…
RecallHealth product recall | 2023-02-09
EVUSHELD (tixagevimab and cilgavimab for injection) - Risk of Prophylaxis or Treatment Failure due to Antiviral Resistance to specific SARS-CoV-2 Subvariants
UPDATED INFORMATION – 2023/01/17
Neutralization data for the following SARS-CoV-2 Omicron subvariants have been added to the Canadian Product Monograph: Omicron BA.2.75.2, BF.7, BJ.1, BN.1, BQ.1, BQ.1.1, and XBB. See Table 1 (below) for a summary…
AlertHealth professional risk communication | 2023-01-17
COMIRNATY Original & Omicron BA.4/BA.5 Bivalent Vaccine with English-only Vial and Carton Labels: New Formulation for Use in Children 5 to Less Than 12 Years of Age
On December 9, 2022, Health Canada authorized a new formulation of the bivalent vaccine, COMIRNATY Original & Omicron BA.4/BA.5, as a booster dose for active immunization against coronavirus disease 2019 (COVID-19) caused by severe acute respiratory…
AlertHealth professional risk communication | 2022-12-09
COMIRNATY Original & Omicron BA.4/BA.5 Bivalent Vaccine with English-only Vial and Carton Labels
On October 7, 2022, Health Canada authorized the bivalent vaccine, COMIRNATY Original & Omicron BA.4/BA.5, as a booster dose for active immunization against coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2…
AlertHealth professional risk communication | 2022-10-07
Health Canada warns about certain hand sanitizers that may pose health risks (Part 2 – March 31, 2021 to present)
Certain lots of hand sanitizers do not meet Health Canada requirements. Issues include:
containing (or possibly containing) ingredients that are not permitted by Health Canada;
containing undeclared impurities at elevated levels;
improper…
AlertPublic advisory | 2022-09-12
Distribution of SPIKEVAX Bivalent (elasomeran/imelasomeran) COVID-19 Vaccine with English-only Vial and Carton Labels
Health Canada authorized SPIKEVAX Bivalent (elasomeran/imelasomeran) on September 01, 2022. In order to provide rapid access to SPIKEVAX Bivalent, Moderna will distribute product vials and cartons labelled in English only with the brand name “SPIKEVAX 0…
AlertHealth professional risk communication | 2022-09-02
Ecotest Covid-19 Antigen Rapid Test Device
Ecotest Covid-19 Antigen Rapid Test Devices were sold without having the proper authorization from Health Canada.
Recall start date: August 11, 2022
RecallHealth product recall | 2022-08-24
Zero Tolerance Plus Sanitizer: Contains undeclared impurity at elevated levels.
Contains undeclared impurity, benzene, at elevated levels.
RecallHealth product recall | 2022-08-15
Distribution of a New Presentation of SPIKEVAX (elasomeran) COVID-19 Vaccine (0.10 mg/mL in 2.5 mL multidose vial) with English-only Vial and Carton Labels
A new presentation of SPIKEVAX (elasomeran) with a concentration of 0.10 mg/mL in a 2.5 mL multidose vial was authorized on June 01, 2022. In order to provide rapid access to the new presentation of SPIKEVAX (0.10 mg/mL, 2.5 mL multidose vial), Moderna…
AlertHealth professional risk communication | 2022-06-06
Surestrips Covid-19 Antigen Test
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…
RecallHealth product recall | 2022-05-30
Surestrips Rapid Response Covid-19 Antigen Rapid Test Device
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.…
RecallHealth product recall | 2022-05-30
The Newfoundland Distillery Company - Fighting Spirit: Acetaldehyde outside acceptable limit
The affected lots may contain an acetaldehyde concentration that is outside the acceptable limit.
RecallHealth product recall | 2022-04-21
Distribution of EVUSHELD (tixagevimab and cilgavimab for injection) with English-Only Vial and Carton Labels
EVUSHELD (tixagevimab and cilgavimab for injection) was authorized by Health Canada on April 14, 2022. In order to provide rapid access to EVUSHELD in the context of the global COVID-19 pandemic, AstraZeneca will distribute product vials and cartons with…
AlertHealth professional risk communication | 2022-04-14
Sotrovimab for Injection - Risk of Treatment Failure due to Circulation of SARS-CoV-2 Omicron BA.2 Subvariant
Sotrovimab, 500 mg IV, is unlikely to maintain efficacy against the Omicron BA.2 subvariant. Sotrovimab demonstrates reduced in vitro neutralization against the Omicron BA.2 subvariant.
Audience
Healthcare professionals responsible…
AlertHealth professional risk communication | 2022-04-14