Public recall detail

Beckman Coulter Au Immunochemi Sys- Unsaturated Iron Binding Capacity (UIBC)

2025-07-09

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Recall Safety notice
Quick summary

Quick summary: Beckman Coulter Au Immunochemi Sys- Unsaturated Iron Binding Capacity (UIBC). Date: 2025-07-09.

Recommended action

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

Recall details

Quick summary: Beckman Coulter Au Immunochemi Sys- Unsaturated Iron Binding Capacity (UIBC). Date: 2025-07-09.

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.
ProductBeckman Coulter Au Immunochemi Sys- Unsaturated Iron Binding Capacity (UIBC)
IssueMedical devices - Performance
Recall classType II
IdentificationRA-77710

Affected products

ProductBeckman Coulter Au Immunochemi Sys- Unsaturated Iron Binding Capacity (UIBC)
LotAll lots.
ModelOSR61205
Serial numberAll lots.
DescriptionBeckman Coulter Au Immunochemi Sys- Unsaturated Iron Binding Capacity (UIBC)

Issue

UIBC OSR61205 is not meeting interference claims for haemoglobin interference serum application. As per product ifus the claim is less than 10% up to 2g/l haemoglobin. While the high pool is meeting the claim, the low pool is failing the hemolysate interference specifications with results of -43.63% or -8.95 μmol/l. Recall start date: July 1, 2025

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-77710
Background{}
CompaniesBeckman Coulter, Inc. 250 S. Kraemer Blvd., Brea, California, United States, 92821
AudiencesHealthcare
Source updated2025-07-09

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

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