Health Products

Xpert® BCR-ABL Ultra

· Published by Health Canada · Official notice

Details

Alert type: Health product recall
Category: Health products - Medical devices - Microbiology
Product: Xpert® BCR-ABL Ultra
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: General public, Healthcare, Industry
Recall class: Type II
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Products

Affected productsLot or serial numberModel or catalogue number
Xpert® BCR-ABL UltraAll lots.GXBCRABL-US-10

Issue

Using Xpert® BCR-ABL Ultra test kits with specimens that have markedly elevated white blood cell count (>30,000 cells/μl) may in rare circumstances cause inaccurate results.

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