Public recall detail

UniCel DxI 600 Access Immunoassay System-Total T4 Assay

2026-03-19

medium
Chemistry Performance
Quick summary

Quick summary: UniCel DxI 600 Access Immunoassay System-Total T4 Assay. Reason: Performance. Category: Chemistry. Date: 2026-03-19.

Recommended action

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

Recall details

Quick summary: UniCel DxI 600 Access Immunoassay System-Total T4 Assay. Reason: Performance. Category: Chemistry. Date: 2026-03-19.

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.
ProductUniCel DxI 600 Access Immunoassay System-Total T4 Assay
IssueMedical devices - Performance
Recall classType II
IdentificationRA-81777

Affected products

ProductUniCel DxI 600 Access Immunoassay System-Total T4 Assay
Lot538815
Model33805
Serial number538815
DescriptionUniCel DxI 600 Access Immunoassay System-Total T4 Assay
ProductUniCel DxI 600 Access Immunoassay System-Total T4 Assay
Lot539243
Model33805
Serial number539243
DescriptionUniCel DxI 600 Access Immunoassay System-Total T4 Assay
ProductUniCel DxI 600 Access Immunoassay System-Total T4 Assay
Lot538729
Model33805
Serial number538729
DescriptionUniCel DxI 600 Access Immunoassay System-Total T4 Assay
ProductUniCel DxI 600 Access Immunoassay System-Total T4 Assay
Lot538898
Model33805
Serial number538898
DescriptionUniCel DxI 600 Access Immunoassay System-Total T4 Assay
ProductUniCel DxI 600 Access Immunoassay System-Total T4 Assay
Lot539107
Model33805
Serial number539107
DescriptionUniCel DxI 600 Access Immunoassay System-Total T4 Assay

Issue

Access Total T4 calibrator lots (PN 33805) exhibit a negative bias on DxI 600/800 instruments, with slopes outside product specifications. In the worst-case scenario, there is a medium safety risk associated with this issue due to the potential to cause false low patient results.

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
Recall date2026-03-10
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-81777
Background{}
CompaniesBeckman Coulter, Inc. 250 S. Kraemer Blvd., Brea, California, United States, 92821
AudiencesHealthcare
Source updated2026-03-19

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

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