Class II U.S. Food and Drug Administration

Cepheid Brand Name: Xpert¿ BCR-ABL Ultra Model/ recall: Invitro diagnostic test kits with specimens that have elevated white blood

Recall published 10 months ago

Invitro diagnostic test kits with specimens that have elevated white blood cell count (>30,000 cell) may cause inaccurate results.

The hazard: Device malfunction

A malfunction was identified in this device. What matters most is whether your particular unit falls inside the affected model, lot or serial range.

What the notice says: Invitro diagnostic test kits with specimens that have elevated white blood cell count (>30,000 cell) may cause inaccurate results.

Why it matters: The device may not perform as intended — a mechanical failure, a software defect, an inaccurate reading, or an alarm that does not sound. For a device someone depends on, the consequence of the failure is usually worse than the failure itself.

Symptoms and when to call a doctor

If the device supports a vital function, do not disable or remove it on your own judgement. Contact the clinician who prescribed or fitted it, and use the back-up arrangement they gave you. Go to an emergency department if the symptoms the device is meant to manage are getting worse, or if an implanted device gives an unexpected alarm or shock.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Recall number
Z-0960-2026
Published
December 24, 2025
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Cepheid
Product type
Medical devices
Units affected
4032 units
Distribution
Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Iowa, Illinois, Kansas, Kentucky, Louisiana, Maryland, Maine, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Hampshire, New Jersey, New York, Ohio, Pennsylvania, Rhode Island, Texas, Virginia, Washington, Wisconsin
Made in
United States
Lot / code info
UDI: 007332940001834/Lot Numbers: 1001452775 1001457465 1001457622 1001459091 1001462586 1001462625 1001463944 1001465391 1001469480 1001473229 1001474930 1001477474 1001480636 1001483324 1001486594 1001492908 1001493823 1001495811 1001498202 1001501650

Products covered by this recall

Brand Name: Xpert¿ BCR-ABL Ultra Model/Catalog Number: GXBCRABL-10

Check your product

The notice names 1 code you can read straight off the package. Type the one printed on yours and the list below narrows to it.

Model or item number

On the rating label, the box or the instruction sheet.

  • GXBCRABL-10 — UDI

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Malfunction

Cepheid — A malfunction was identified in this device. What matters most is whether your particular unit falls inside the affected model, lot or serial range.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers listed on this page.
  2. Check whether the remedy is a software update, and if so confirm afterwards in the device menu that the version actually changed.
  3. If you are a clinic or facility, quarantine affected stock and record the correction in your recall log.
  4. Report device problems to the FDA through MedWatch — that database is where this recall came from.

Who pays for a device recall

The manufacturer funds the remedy. The practical question is usually which link in the chain executes it.

  • If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.
  • Ask for written confirmation that the remedy was applied to your serial number. That is what an insurer or a future clinician will want to see.
  • If you bought it yourself online or from a pharmacy, go to the manufacturer’s recall page rather than the retailer; device claims are handled centrally.
  • Where the remedy is a software update, there is nothing to claim, but do confirm the version changed afterwards.

Company contact: Cepheid — 904 E Caribbean Dr, Sunnyvale, CA, 94089-1189

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Cepheid medical devices recalled?

Invitro diagnostic test kits with specimens that have elevated white blood cell count (>30,000 cell) may cause inaccurate results. Invitro diagnostic test kits with specimens that have elevated white blood cell count (>30,000 cell) may cause inaccurate results.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: model number GXBCRABL-10 — UDI. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers listed on this page.

Can I get my money back?

If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.

Which states were affected?

The notice lists Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Iowa, Illinois, Kansas, Kentucky, Louisiana and others.

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