FDA device enforcement
Xpert MTB/RIF. Model Number: GXMTB/RIF-US-10.
Product testing did not meet expected stability criteria.
Class IIReported ongoing
Distribution: US Nationwide distribution and Puerto Rico.
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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. Source coverage and dates.
Records and reported status
Official source for Xpert MTB/RIF. Model Number: GXMTB/RIF-US-10.
FDA device enforcement
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 IIReported 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 ...
FDA device enforcement
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 IIReported 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 ...
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...
As a result of Post-Market half-time stability testing, false negative test result was observed for a positive sample type.
Class IIReported 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...
FDA device enforcement
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 IIReported 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, ...
FDA device enforcement
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 IIReported 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...
FDA device enforcement
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 IIReported 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...
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 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 and the agency's current notices.
Where can I find older records?
Use monthly 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.