Cepheid
Sunnyvale, CA
This page shows every FDA and USDA recall linked to Cepheid. Each entry includes the product involved, when the recall happened, and how serious it was. If a company has had multiple recalls over the years, you can see the full history here in one place — including whether any were Class I, which is the most serious type.
19
Total Recalls
2005
First Recall
2025
Most Recent
Brand Name: Xpert BCR-ABL Ultra
Model/Catalog Number: GXBCRABL-US-10
Dec 18, 2025
· Device
Open, Classified
Brand Name: Xpert BCR-ABL Ultra
Model/Catalog Number: GXBCRABL-10
Dec 18, 2025
· Device
Open, Classified
Xpert MTB/RIF. Model Number: GXMTB/RIF-US-10.
Nov 26, 2025
· Device
Open, Classified
Xpert SA Nasal Complete
Catalog Number: GXSACOMP-10
UDI-DI code: 07332940000158
Xpert SA Nasal Complete kit;...
Oct 30, 2025
· Device
Open, Classified
Cepheid, Sample Collection Device, Part: 900-0370
Aug 14, 2024
· Device
Open, Classified
Xpert Xpress Strep A, REF:Xprstrepa-CE-10, CE IVD,
Nov 2, 2023
· Device
Open, Classified
Xpert Xpress Strep A, XPRSTREPA-10, P/N: 302-2294 IVD, Rx Only
Nov 2, 2023
· Device
Open, Classified
Xpert CT/NG Catalog GXCT/NG-120 Batch 1000049568, Catalog GXCT/NG-10 Batch 1000053075, Catalog GXCT/NG-10 Batc...
Oct 9, 2017
· Device
Terminated
Xpert EV Assay, Catalog GXEV-100N-10.
The Cepheid Xpert EV assay is a reverse transcription polymerase chain...
Sep 15, 2017
· Device
Terminated
Xpert MRSA
Catalog GXMRSA-120, Rev. AJ
Microbiology:
The Cepheid Xpert MRSA assay performed in the GeneXpert...
Jul 18, 2016
· Device
Terminated
Xpert CT /NG Vaginal/Endocervical/ Specimen Collection Kit:
Part number CT/NGSWAB-50;
Microbiology: The Cephe...
Aug 20, 2015
· Device
Terminated
Xpert CT/NG Urine Specimen Collection Kit
Part number GXCT/NGURINE-50;
Microbiology: Xpert CT/NG Urine Specim...
Aug 20, 2015
· Device
Terminated
Cepheid brand Xpert MRSA/SA-BC US-IVD, an In-vitro diagnostic test kit, Catalog Numbers: GXMRSA/SA-BC-10, Lots...
Jan 11, 2012
· Device
Terminated
Xpert Infinity Software, V 4.1a.
Cepheid, Sunnyvale, CA 94089
system software for GeneXpert Infinity 48
May 31, 2011
· Device
Terminated
Cepheid Xpert MRSA/SA Blood Culture Test for use with the GeneXpert Dx System, manufactured by Cepheid, Sunnyv...
Jul 1, 2010
· Device
Terminated
Cepheid Xpert Flu A Panel (GXFLUPANEL-10), manufactured by Cepheid, Sunnyvale, CA.
Indicated as an automated...
May 25, 2010
· Device
Terminated
Cepheid Xpert Flu A Panel (GXFLUPANEL-CE-10), manufactured by Cepheid, Sunnyvale, CA.
Indicated as an automat...
May 25, 2010
· Device
Terminated
Cepheid, Xpert GBS Assay Diagnostic Test Kit Part No: GXGBS-100N-10 (in foil pouch) for use with the GeneXper...
Jan 12, 2008
· Device
Terminated
SmartCycler Diagnostic Software for use with Cepheid brand SmartCycler Real Time PCR Thermocycler
Aug 17, 2005
· Device
Terminated