Public recall detail

Access System - Free T3 Assays

2023-03-29

medium
Recall Safety notice
Quick summary

Quick summary: Access System - Free T3 Assays. Date: 2023-03-29.

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 - Free T3 Assays. Date: 2023-03-29.

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 - Free T3 Assays
IssueMedical devices - Performance
Recall classType II
IdentificationRA-73409

Affected products

ProductUnicel DxI 600 Access Immunoassay System - Free T3 Assay
Lot233968
ModelA13422
Serial number233968
DescriptionUnicel DxI 600 Access Immunoassay System - Free T3 Assay
ProductUnicel DxI 800 Access Immunoassay System - Free T3 Assay
Lot233968
ModelA13422
Serial number233968
DescriptionUnicel DxI 800 Access Immunoassay System - Free T3 Assay
ProductAccess System - Free T3 Assay
Lot233968
ModelA13422
Serial number233968
DescriptionAccess System - Free T3 Assay

Issue

Beckman Coulter has determined that Access Free T3 reagent lot 233968 included an insufficient concentration of blocking reagent. Patient samples tested with Access Free T3 reagent lot 233968 may demonstrate repeatable falsely elevated results, which are caused by insufficiently blocked interferents. Recall start date: March 20, 2023

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-73409
Background{}
CompaniesBeckman Coulter, Inc. 250 S. Kraemer Blvd., Brea, California, United States, 92821
AudiencesHealthcare
Source updated2023-03-29

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

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