Public recall detail

Alinity M System

2024-04-08

medium
Recall Safety notice
Quick summary

Quick summary: Alinity M System. Date: 2024-04-08.

Recommended action

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

Recall details

Quick summary: Alinity M System. Date: 2024-04-08.

Official details

Affected product details

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

BrandAbbott Molecular Inc.
ProductAlinity M System
IssueMedical devices - Performance
Recall classType II
IdentificationRA-75361

Affected products

ProductAlinity M System
LotAll lots.
Model08N53-002
Serial numberAll lots.
DescriptionAlinity M System

Issue

Abbott has identified an issue concerning the use of certain third-party universal transport medium (UTM) tubes on the Alinity M System. This issue has been observed with Copan® UTM-RT 3 mL without beads transport & preservation medium for viral molecular diagnostics testing, part number (PN) 3C047N. However, it is possible that other third party manufactured tubes could experience the same issue. Recall Start Date: March 22, 2024

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - Chemistry
CompaniesAbbott Molecular Inc. 1300 E. Touhy Ave., Des Plaines, Illinois, United States, 60018
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-75361
Background{}
CompaniesAbbott Molecular Inc. 1300 E. Touhy Ave., Des Plaines, Illinois, United States, 60018
AudiencesHealthcare
Source updated2024-04-08

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

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