Health product recall

Xpert® BCR-ABL Ultra

Brand(s)
Last updated

Summary

Product
Xpert® BCR-ABL Ultra
Issue
Medical devices - Performance
What to do

Contact the manufacturer if you require additional information. 

Affected products

Affected products Lot or serial number Model or catalogue number
Xpert® BCR-ABL Ultra All 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.

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Microbiology
Companies
Cepheid
904 E Caribbean Drive, Sunnyvale, California, United States, 94089
Published by
Health Canada
Audience
General public
Healthcare
Industry
Recall class
Type II
Recall date
Identification number
RA-81240

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