Sunnyvale, CA, United States
Cepheid recalls
6 recalls recorded since 2018, most recently on 5 November 2025. 5 are listed as ongoing. Status and classification are as published by the FDA.
Recalls6
Ongoing (FDA)5
Terminated or completed1
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 5 November 2025
- Reason
- Product testing did not meet expected stability criteria.
- Distribution
- US Nationwide distribution and Puerto Rico.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0724-2026
- Xpert MTB/RIF. Model Number: GXMTB/RIF-US-10.
Ongoing Class II Medical devices
- Recall started
- 30 October 2025
- Reason
- Invitro diagnostic test kits with specimens that have elevated white blood cell count (>30,000 cell) may cause inaccurate results.
- 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 Sal
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0960-2026, Z-0959-2026
- Brand Name: Xpert¿ BCR-ABL Ultra Model/Catalog Number: GXBCRABL-10
- Brand Name: Xpert¿ BCR-ABL Ultra Model/Catalog Number: GXBCRABL-US-10
Ongoing Class II Medical devices
- Recall started
- 6 August 2025
- Reason
- As a result of Post-Market half-time stability testing, false negative test result was observed for a positive sample type.
- 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, OH, OK, OR, PA, PR, SC, TN, TX, UT, VA, WA, WI, WV, and WY.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0414-2026
- 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 intended to be used for the direct qu
Ongoing Class II Medical devices
- Recall started
- 20 June 2024
- Reason
- 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.
- 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, AZ, OR, MI, IN, TN, AL, KS, ME, AR, NV, HI, AK, NM, WY, VT, ND, DC OUS (foreign) to countries of: Chile, Ireland, Oman, Ni
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2584-2024
- Cepheid, Sample Collection Device, Part: 900-0370
Ongoing Class II Medical devices
- Recall started
- 24 April 2023
- Reason
- 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.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Costa Rica, Ireland, Estonia, United Kingdom, Germany, Italy, Greece, Poland, Switzerland, Hong Kong, United Arab Emirates.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0216-2024, Z-0215-2024
- Xpert Xpress Strep A, REF:Xprstrepa-CE-10, CE IVD,
- Xpert Xpress Strep A, XPRSTREPA-10, P/N: 302-2294 IVD, Rx Only
Terminated Class II Medical devices
- Recall started
- 9 October 2017
- Terminated
- 13 February 2018
- Reason
- Cepheid has received reports that some of our customers have experienced a higher number of temperature drift errors than would typically be expected when using this test and its intended use specimen types. Investigation of the issue also revealed an occasional probability of false negative results which remains consistent with package insert claims.
- Distribution
- Worldwide Distribution -- USA, Puerto Rico, and Haiti.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0592-2018
- Xpert CT/NG Catalog GXCT/NG-120 Batch 1000049568, Catalog GXCT/NG-10 Batch 1000053075, Catalog GXCT/NG-10 Batch 1000056156 and Catalog GXCT/NG-10 Batch 1000056157. Is a qualitative in vitro real-time PCR test.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.