CanadaCepheid Xpert BCR-ABL Ultra test kits (model/catalogue GXBCRABL‑US‑10; all lots) are affected and can be identified by the product name and model number. Use of these kits with specimens that have markedly elevated white blood cell counts (>30,000 cells/μl) may in rare circumstances cause inaccurate results. Contact the manufacturer for additional information.
What's being recalled
Companies: Cepheid, 904 E Caribbean Drive, Sunnyvale, California, United States, 94089.
How to identify it
Affected products: Xpert® BCR-ABL Ultra; Lot or serial number: All lots.; Model or catalogue number: GXBCRABL-US-10
The hazard
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.
What to do
Contact the manufacturer if you require additional information.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)
United States