Health Products

iQ200 Series Analyzers and DxU 840m/850m Iris Analyzers

· Published by Health Canada · Official notice

Details

Alert type: Health product recall
Category: Health products - Medical devices - Chemistry
Product: iQ200 Series Analyzers and DxU 840m/850m Iris Analyzers
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 catalogue number
DxU 840m IrisMore than 10 numbers, contact manufacturer.C76947
iQ200 SPRINT 2008 TestedMore than 10 numbers, contact manufacturer.700-3325
iQ200 SELECT 2008 TestedMore than 10 numbers, contact manufacturer.700-3345
DxU 850m IrisMore than 10 numbers, contact manufacturer.C49513
iQ200 ELITE 2008 TestedMore than 10 numbers, contact manufacturer.700-3375

Issue

Beckman Coulter received customer complaints of lamina fluid leaks in iQ200 Series and DxU 840m/850m Analyzers. The investigation found that a structurally compromised rinse-line check valve may allow fluid to migrate internally and leak onto the table or floor, potentially resulting into exposure to physical or mechanical or chemical hazards.

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