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Beckman coulter au immunochemi sys- unsaturated iron binding capacity (uibc)

Official notice

9 Jul 2025

Last checked

9 Jul 2025

Medium riskHealth Canada
Watch Beckman Coulter

An official Health Canada notice concerns Beckman coulter au immunochemi sys- unsaturated iron binding capacity (uibc). 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 Published 2025-07-09.

What to do now

Contact the manufacturer if you require additional information.

Recall number

77710

Official notice

2025-07-09

The hazard

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

How to check if you're affected

Compare the VIN on your vehicle against the official list. If your VIN is listed, follow the official notice.

Recall Numbers

77710

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Affected products

Product 1

Affected products - Beckman Coulter Au Immunochemi Sys- Unsaturated Iron Binding Capacity (UIBC), Lot or serial number - All lots., Model or catalog number - OSR61205

Risk / hazard

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

Where it was sold

The source does not list specific retailers. See the official notice for where affected vehicles were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Brand

Beckman Coulter, Beckman Coulter Au Immunochemi Sys- Unsaturated Iron Binding Capacity

Manufacturer

Not provided

Phone

Not provided

Brand: Beckman Coulter, Beckman Coulter Au Immunochemi Sys- Unsaturated Iron Binding Capacity.

Source & status

Source

Health Canada

Tier

official

Category

HOME

Classification

Type II

App estimate

medium

Recall details

Recall number

77710

Classification

Type II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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