--- title: "Cepheid Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search Cepheid recall records, lots, firms and dates. Reported status can be incomplete; use the linked agency notice for current instructions." url: https://isitonrecall.com/brand/cepheid/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # Cepheid recall records **7** reported ongoing 7 records in this archive. Latest source date Nov 5, 2025. FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## Records and reported status Nov 5, 2025 FDA device enforcement ### [Xpert MTB/RIF. Model Number: GXMTB/RIF-US-10.](https://isitonrecall.com/recall/fda-device-z-0724-2026-xpert-mtb-rif-model-number-gxmtb-rif-us-10/) Product testing did not meet expected stability criteria. Class II Reported ongoing Distribution: US Nationwide distribution and Puerto Rico. [Official source for Xpert MTB/RIF. Model Number: GXMTB/RIF-US-10.](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0724-2026%22) Oct 30, 2025 FDA device enforcement ### [Brand Name: Xpert¿ BCR-ABL Ultra Model/Catalog Number: GXBCRABL-US-10](https://isitonrecall.com/recall/fda-device-z-0959-2026-brand-name-xpert-bcr-abl-ultra-model-catalog-number-gxbcrabl-us-10/) Invitro diagnostic test kits with specimens that have elevated white blood cell count (>30,000 cell) may cause inaccurate results. Class II Reported ongoing 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 ... [Official source for Brand Name: Xpert¿ BCR-ABL Ultra Model/Catalog Number: GXBCRABL-US-10](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0959-2026%22) Oct 30, 2025 FDA device enforcement ### [Brand Name: Xpert¿ BCR-ABL Ultra Model/Catalog Number: GXBCRABL-10](https://isitonrecall.com/recall/fda-device-z-0960-2026-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. Class II Reported ongoing 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 ... [Official source for Brand Name: Xpert¿ BCR-ABL Ultra Model/Catalog Number: GXBCRABL-10](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0960-2026%22) Aug 6, 2025 FDA device enforcement ### [Xpert SA Nasal Complete Catalog Number: GXSACOMP-10 UDI-DI code: 07332940000158 Xpert SA Nasal Complete kit; 10 test kit: A collection of reagents and other associated materials...](https://isitonrecall.com/recall/fda-device-z-0414-2026-xpert-sa-nasal-complete-catalog-number-gxsacomp-10-udi-di-code-07332940000158-xpert-sa-nasal-complet/) As a result of Post-Market half-time stability testing, false negative test result was observed for a positive sample type. Class II Reported ongoing Distribution: U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NV, NY, O... [Official source for Xpert SA Nasal Complete Catalog Number: GXSACOMP-10 UDI-DI code: 07332940000158 Xpert SA Nasal Co...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0414-2026%22) Jun 20, 2024 FDA device enforcement ### [Cepheid, Sample Collection Device, Part: 900-0370](https://isitonrecall.com/recall/fda-device-z-2584-2024-cepheid-sample-collection-device-part-900-0370/) Specimen collection device may leak after the patient sample swabs have been inserted into the test tubes, which could result in biohazard exposure, cross contamination causing false positive results for other specimens, and/or delay to test results. Class II Reported ongoing Distribution: Worldwide distribution: US (nationwide): IL, TX, OH, LA, NY, CA, MD, IA, MN, KY, NH, WI, MO, NC, UT, WA, FL, NJ, SC, CO, PA, SD, NE, MT, WV, GA, MA, RI, CT, DE, MS, OK, VA, ID, ... [Official source for Cepheid, Sample Collection Device, Part: 900-0370](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2584-2024%22) Apr 24, 2023 FDA device enforcement ### [Xpert Xpress Strep A, XPRSTREPA-10, P/N: 302-2294 IVD, Rx Only](https://isitonrecall.com/recall/fda-device-z-0215-2024-xpert-xpress-strep-a-xprstrepa-10-p-n-302-2294-ivd-rx-only/) pipettes packaged in Strep A test may fail to dispense an adequate sample volume which could result in "invalid" results or no result test results. Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide and the countries of Costa Rica, Ireland, Estonia, United Kingdom, Germany, Italy, Greece, Poland, Switzerland, Hong Kong, United Arab Emi... [Official source for Xpert Xpress Strep A, XPRSTREPA-10, P/N: 302-2294 IVD, Rx Only](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0215-2024%22) Apr 24, 2023 FDA device enforcement ### [Xpert Xpress Strep A, REF:Xprstrepa-CE-10, CE IVD,](https://isitonrecall.com/recall/fda-device-z-0216-2024-xpert-xpress-strep-a-ref-xprstrepa-ce-10-ce-ivd/) pipettes packaged in Strep A test may fail to dispense an adequate sample volume which could result in "invalid" results or no result test results. Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide and the countries of Costa Rica, Ireland, Estonia, United Kingdom, Germany, Italy, Greece, Poland, Switzerland, Hong Kong, United Arab Emi... [Official source for Xpert Xpress Strep A, REF:Xprstrepa-CE-10, CE IVD,](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0216-2024%22) ## Reasons in these listed records - Product testing did not meet expected stability criteria. - Invitro diagnostic test kits with specimens that have elevated white blood cell count (>30,000 cell) may cause inaccurate results. - As a result of Post-Market half-time stability testing, false negative test result was observed for a positive sample type. - Specimen collection device may leak after the patient sample swabs have been inserted into the test tubes, which could result in biohazard exposure, cross contamination causing false positive results for other specimens, and/or delay to test results. These examples come from this result page and are not a ranking of every recall reason. ## Checking Cepheid ### Is there a recall on cepheid right now? This archive contains 7 records, including 7 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product. ### How do I check my package or product? Compare the product, firm and lot, date, model or serial identifiers with the notice. [Use the label-check guide](https://isitonrecall.com/guides/read-lot-codes/) if you need help locating an identifier. ### Does a matching name mean every item is included? A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall. ### What if the search finds no matching record? This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. [Check source coverage](https://isitonrecall.com/sources/) and the agency's current notices. ### Where can I find older records? Use [monthly archives](https://isitonrecall.com/archives/) or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page. ## Keep checking [Search Cepheid](https://isitonrecall.com/check/?q=Cepheid) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)