Public recall detail

Simplexa Covid-19 Direct

2023-02-08

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Recall Safety notice
Quick summary

Quick summary: Simplexa Covid-19 Direct. Date: 2023-02-08.

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. Date: 2023-02-08.

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
IssueMedical devices - Performance COVID
Recall classType II
IdentificationRA-72669

Affected products

ProductSimplexa Covid-19 Direct
Lot13967N 13968N 15061N 13330N 13331N 14016N 13336N
ModelMOL4150
Serial number13967N 13968N 15061N 13330N 13331N 14016N 13336N
DescriptionSimplexa Covid-19 Direct

Issue

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 version 2. No disc leakage occurred with version 3 (reduced spin & temp). Simplexa Flu A/B & RSV (mol2655) and Simplexa Covid-19 & Flu A/B Direct (mol4250) have similar assay definitions and are also at risk for leakage. Recall start date: February 01, 2023

What you should do

  • Discontinue using remaining inventory, share recall notice with users, complete/return response form.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - Microbiology
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-72669
Background{}
CompaniesDiasorin Molecular LLC 11331 Valley View Street, Cypress, California, United States, 90630
AudiencesHealthcare
Source updated2023-02-09

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

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