Public recall detail

Actim Prom And Actim Partus

2023-12-04

medium
Recall Safety notice
Quick summary

Quick summary: Actim Prom And Actim Partus. Date: 2023-12-04.

Recommended action

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

Recall details

Quick summary: Actim Prom And Actim Partus. Date: 2023-12-04.

Official details

Affected product details

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

BrandActim Oy
ProductActim Prom And Actim Partus
IssueMedical devices - Performance
Recall classType II
IdentificationRA-74671

Affected products

ProductActim Prom
LotAll lots.
Model30831ETAL 30832ETAL
Serial numberAll lots.
DescriptionActim Prom
ProductActim Partus
LotAll lots.
Model31931ETAL
Serial numberAll lots.
DescriptionActim Partus

Issue

Our recent interference testing has shown that the presence of lubricants in the vaginal specimen may interfere with the prom test result, which deviates from what is presented in the instructions for use. The defectiveness was discovered 2023-11-08. This is not a lot specific issue. Recall Start Date: November 12, 2023

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - Chemistry
CompaniesActim Oy Klovinpellontie 3, Espoo, Finland, 02180
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-74671
Background{}
CompaniesActim Oy Klovinpellontie 3, Espoo, Finland, 02180
AudiencesHealthcare
Source updated2023-12-04

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

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