Cepheid recalls Xpert BCR-ABL Ultra test kits with elevated white blood cell counts that may cause inaccurate results. Affected kits have specific model and lot numbers.
Invitro diagnostic test kits with specimens that have elevated white blood cell count (>30,000 cell) may cause inaccurate results.
Cepheid is recalling Xpert BCR-ABL Ultra test kits that may give inaccurate results when specimens have elevated white blood cell counts. This could lead to incorrect health assessments if used without proper validation.
These test kits may produce incorrect results when specimens have white blood cell counts above 30,000 cells per microliter. This could lead to wrong health conclusions if the test is used without proper validation.
People using these test kits for blood tests at home or in clinics may be affected. Those with elevated white blood cell counts are most at risk of inaccurate results.
Check for model number GXBCRABL-US-10 and lot numbers: 1001456698, 1001463946, 1001472599, 1001477457, 1001480637, 1001483326, 1001500425. The kits are sold by Cepheid.
Review the model number and lot numbers listed to confirm if your kit is affected.
The test kits may give inaccurate results when specimens have elevated white blood cell counts above 30,000 cells per microliter.
The recall record does not specify a remedy, so check the kit details to see if it is affected.
Look for model number GXBCRABL-US-10 and lot numbers: 1001456698, 1001463946, 1001472599, 1001477457, 1001480637, 1001483326, 1001500425.
We’ve drafted a message you can send Cepheid to request your refund or repair — edit it as you like.
Subject: Recall Z-0959-2026 — Cepheid Cepheid Hello, I own a Cepheid that is covered by recall Z-0959-2026 from Cepheid. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
