Public recall detail

Access System - Total T4 Assay

2024-02-15

medium
Recall Safety notice
Quick summary

Quick summary: Access System - Total T4 Assay. Date: 2024-02-15.

Recommended action

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

Recall details

Quick summary: Access System - Total T4 Assay. Date: 2024-02-15.

Official details

Affected product details

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

BrandBECKMAN COULTER, INC.
ProductAccess System - Total T4 Assay
IssueMedical devices - Performance
Recall classType II
IdentificationRA-75075

Affected products

ProductAccess System - Total T4 Assay
Lot338555 338734 338958 338556
Model33800
Serial number338555 338734 338958 338556
DescriptionAccess System - Total T4 Assay

Issue

Beckman Coulter has determined that the affected Access Total T4 reagent lots demonstrate an assay imprecision that is higher than expected. An unusual amount of precipitate may be observed in the Access Total T4 reagent packs. Recall start date: February 5, 2024

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - Chemistry
CompaniesBeckman Coulter, Inc. 250 S. Kraemer Blvd., Brea, California, United States, 92821
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-75075
Background{}
CompaniesBeckman Coulter, Inc. 250 S. Kraemer Blvd., Brea, California, United States, 92821
AudiencesHealthcare
Source updated2024-02-15

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

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