Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported December 24, 2025
Brand Name: Xpert¿ BCR-ABL Ultra Model/Catalog Number: GXBCRABL-10
Invitro diagnostic test kits with specimens that have elevated white blood cell count (>30,000 cell) may cause inaccurate results.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Cepheid recalled Brand Name: Xpert¿ BCR-ABL Ultra Model/Catalog Number: GXBCRABL-10 - a moderate-severity action.
Brand Name: Xpert¿ BCR-ABL Ultra Model/Catalog Number: GXBCRABL-10 was recalled by Cepheid in December 24, 2025. Reason: Invitro diagnostic test kits with specimens that have elevated white blood cell count (>30,000 cell) may caus…. Check the official notice for the remedy. Verify recall #Z-0960-2026 with the FDA Devices before acting.
The recall
Cepheid issued this moderate-severity FDA Devices recall-Invitro diagnostic test kits with specimens that have elevated white blood cell count (>30,000 cell) may caus….
- Moderate
- severity level
- 4K units
- affected scope
- Class II
- classification
- December 24, 2025
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0960-2026 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0960-2026) was formally reported on December 24, 2025, with the manufacturer initiating the action on October 30, 2025. It is classified under Moderate severity (Class II), with a current status of Ongoing. Cepheid is listed as the recalling firm, operating out of Sunnyvale, CA. Federal records list the affected scope as 4032 units.
The documented reason for this recall is: Invitro diagnostic test kits with specimens that have elevated white blood cell count (>30,000 cell) may cause inaccurate results. Distribution data in the federal record shows the product reached: US: AL AR AZ CA CO FL GA IA IL KS KY LA MD ME MI MN MO NC NE NH NJ NY OH PA RI TX VA WA WI OUS: Algeria Armenia Australia Austria Bahrain Bangladesh Belgium Brazil Burkina Faso Cambodia Canada Canary islands Chile Colo…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
4032 units
Related Recalls
6
3 from same agency
Product description
Brand Name: Xpert¿ BCR-ABL Ultra Model/Catalog Number: GXBCRABL-10
Reason for recall
Invitro diagnostic test kits with specimens that have elevated white blood cell count (>30,000 cell) may cause inaccurate results.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-0960-2026 |
| Date reported | December 24, 2025 |
| Date initiated | October 30, 2025 |
| Recalling firm | Cepheid |
| Firm location | Sunnyvale, CA |
| Affected scope | 4032 units |
| Distribution | US: AL AR AZ CA CO FL GA IA IL KS KY LA MD ME MI MN MO NC NE NH NJ NY OH PA RI TX VA WA WI OUS: Algeria Armenia Australia Austria Bahrain Bangladesh Belgium Brazil Burkina Faso Cambodia Canada Canary islands Chile Colombia Cyprus Czech Re… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0960-2026) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Brand Name: Xpert¿ BCR-ABL Ultra Model/Catalog Number: GXBCRABL-10. Recalled by Cepheid. Units affected: 4032 units.
Why was this product recalled? ▼
Invitro diagnostic test kits with specimens that have elevated white blood cell count (>30,000 cell) may cause inaccurate results.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 24, 2025. Severity: Moderate. Recall number: Z-0960-2026.
Where was the recalled product distributed? ▼
Distribution: US: AL AR AZ CA CO FL GA IA IL KS KY LA MD ME MI MN MO NC NE NH NJ NY OH PA RI TX VA WA WI OUS: Algeria Armenia Australia Austria Bahrain Bangladesh Belgium Brazil Burkina Faso Cambodia Canada Canary islands Chile Colombia Cyprus Czech Republic Dem. Rep. Congo Djibouti Dominican Rep. Ecuador El Salvador Eswatini Finland France Frenc.Polynesia Gambia Georgia Germany Ghana Greece Guadeloupe Guatemala Honduras Hong Kong India Indonesia Iraq Israel Italy Jamaica Jordan Kazakhstan Kenya Kuwait Latvia Lebanon Lithuania Luxembourg Malawi Malaysia Mauritania Mauritius Mexico Morocco Mozambique Myanmar Netherlands New Caledonia New Zealand Nicaragua Norway Oman Pap. New Guinea Peru Philippines Poland Portugal Qatar Rep.of Congo Reunion Rwanda Saudi Arabia Senegal Seychelles Singapore South Africa Spain Sri Lanka Sweden Switzerland Taiwan Tajikistan Tanzania Thailand Togo Tunisia Uganda United Kingdom Uruguay Utd.Arab Emir. Venezuela Zambia Zimbabwe.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0960-2026) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported December 24, 2025. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.