Health Products

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

· Published by Health Canada · Official notice

Details

Alert type: Health product recall
Category: Health products - Medical devices - Chemistry
Product: Beckman Coulter Au Immunochemi Sys- Unsaturated Iron Binding Capacity (UIBC)
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare
Recall class: Type II
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Products

Affected productsLot or serial numberModel or catalog number
Beckman Coulter Au Immunochemi Sys- Unsaturated Iron Binding Capacity (UIBC)All lots.OSR61205

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

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