Reported Dec 24, 2025 · Ongoing
Brand Name: Xpert¿ BCR-ABL Ultra Model/Catalog Number: GXBCRABL-US-10
Cepheid
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Cepheid · 904 E Caribbean Dr · Sunnyvale, CA · 94089-1189
Is this the product you have?
- Brand NameXpert¿
- BCR-ABL Ultra Model/Catalog NumberGXBCRABL-US-10
- Lot codes and dates
- UDI07332940007102/
- Lot Numbers
1001456698100146394610014725991001477457100148063710014833261001500425
- Amount recalled
- 6325 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Invitro diagnostic test kits with specimens that have elevated white blood cell count (>30,000 cell) may cause inaccurate results.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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