Cepheid recalls Xpert BCR-ABL Ultra test kits with elevated white blood cell counts that may cause inaccurate results. Affected kits have specific model numbers 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 diagnoses if used without the recall fix.
The test kits may produce inaccurate results when specimens have white blood cell counts above 30,000 cells per microliter. This could lead to incorrect health conclusions if the test is used without the recall fix.
People using these test kits for blood tests with elevated white blood cell counts. Those with specific model numbers and lot numbers listed in the recall are most at risk.
Check for the model number GXBCRABL-10 and lot numbers listed: 1001452775, 1001457465, 1001457622, 1001459091, 1001462586, 1001462625, 1001463944, 1001465391, 1001469480, 1001473229, 1001474930, 1001477474, 1001480636, 1001483324, 1001486594, 1001492908, 1001493823, 1001495811, 1001498202, 1001501650.
Look for the model number GXBCRABL-10 and lot numbers listed in the recall notice.
The test kits may give inaccurate results when specimens have elevated white blood cell counts above 30,000 cells per microliter.
The recall notice does not specify a remedy, so check the official Cepheid website for further instructions.
Lot numbers 1001452775, 1001457465, 1001457622, 1001459091, 1001462586, 1001462625, 1001463944, 1001465391, 1001469480, 1001473229, 1001474930, 1001477474, 1001480636, 1001483324, 1001486594, 1001492908, 1001493823, 1001495811, 1001498202, 1001501650.
We’ve drafted a message you can send Cepheid to request your refund or repair — edit it as you like.
Subject: Recall Z-0960-2026 — Cepheid Cepheid Hello, I own a Cepheid that is covered by recall Z-0960-2026 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.
