Public recall detail

Simplexa Covid-19 Direct Assay

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Recall Safety notice
Quick summary

Quick summary: Simplexa Covid-19 Direct Assay.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: Simplexa Covid-19 Direct Assay.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandDiasorin Molecular LLC
ProductSimplexa Covid-19 Direct Assay
IssueMedical devices - Manufacturing defect
Recall classType II
IdentificationRA-63807

Affected products

ProductSimplexa Covid-19 Direct Assay
Lot12501N, 11269N, 13183N, 12348N, 11784N
ModelMOL4150
Serial number12501N, 11269N, 13183N, 12348N, 11784N
DescriptionSimplexa Covid-19 Direct Assay

Issue

It was recently internally identified that five (5) lots of Simplexatm COVID-19 direct (Ref MOL4150) were shipped to Canada that had been manufactured with the recombinant hot start polymerase produced by Diasorin S.P.A. instead of the enzyme from an external supplier. While the validation for the material made by Diasorin S.P.A. had been successfully completed, the change had not yet been approved by Health Canada for use in products shipped to Canada patient results are not impacted by this compliance related issue. Recall start date: Jan 7, 2022

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceGeneral public Health professionals Hospitals
CategoryHealth products - Medical devices
CompaniesDiasorin Molecular LLC 11331 Valley View Street, Cypress, California United States, 90630
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-63807
Background{}
CompaniesDiasorin Molecular LLC 11331 Valley View Street, Cypress, California United States, 90630
AudiencesGeneral public Health professionals Hospitals
Source updated2022-01-10

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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