Cepheid recalls

Cepheid has 12 recalls on record with the FDA and USDA, the earliest in 2015 and the latest reported on 24 Dec 2025. 7 are still ongoing. 4 were reported in the last 12 months. The most frequent reason is potency & assay.

Total recalls12since 2015

Last 12 months4reported

Class I00% of total

Ongoing7latest 24 Dec 2025

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 0Oct 1 3 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 0 0%Class II 10 83%Class III 2 17%

Why cepheid is recalled

Product types

By year

2025433%
202418%
2023217%
201818%
201718%
201618%
2015217%

Ongoing cepheid recalls

7 active

Reported	Class	Recall	Company	Reason	Where
24 Dec 2025Device	CLASS II	Xpert¿ Bcr-abl Ultra recalled by Cepheid	Cepheid	Labeling Errors	27 states
24 Dec 2025Device	CLASS II	Xpert¿ Bcr-abl Ultra recalled by Cepheid	Cepheid	Labeling Errors	27 states
3 Dec 2025Device	CLASS II	Xpert MTB/RIF recalled by Cepheid	Cepheid	Potency & Assay	Nationwide
5 Nov 2025Device	CLASS II	Xpert SA Nasal Complete recalled by Cepheid	Cepheid	Potency & Assay	Nationwide
21 Aug 2024Device	CLASS II	Sample Collection Device, Part recalled by Cepheid	Cepheid	Packaging Defects	Nationwide
8 Nov 2023Device	CLASS II	Xpert Xpress Strep A, Xprstrepa recalled by Cepheid	Cepheid	Packaging Defects	Nationwide

All cepheid recalls, newest first

12 total

Reported	Class	Recall	Company	Reason	Where
24 Dec 2025Device	CLASS II	Xpert¿ Bcr-abl Ultra recalled by Cepheid	Cepheid	Labeling Errors	27 states
24 Dec 2025Device	CLASS II	Xpert¿ Bcr-abl Ultra recalled by Cepheid	Cepheid	Labeling Errors	27 states
3 Dec 2025Device	CLASS II	Xpert MTB/RIF recalled by Cepheid	Cepheid	Potency & Assay	Nationwide
5 Nov 2025Device	CLASS II	Xpert SA Nasal Complete recalled by Cepheid	Cepheid	Potency & Assay	Nationwide
21 Aug 2024Device	CLASS II	Sample Collection Device, Part recalled by Cepheid	Cepheid	Packaging Defects	Nationwide
8 Nov 2023Device	CLASS II	Xpert Xpress Strep A, Xprstrepa recalled by Cepheid	Cepheid	Packaging Defects	Nationwide
8 Nov 2023Device	CLASS II	Xpert Xpress Strep recalled by Cepheid	Cepheid	Packaging Defects	Nationwide
21 Feb 2018Device	CLASS II	Xpert CT/NG recalled by Cepheid	Cepheid	Packaging Defects	PR
25 Oct 2017Device	CLASS II	Xpert EV Assay recalled by Cepheid	Cepheid	Potency & Assay	CA
24 Aug 2016Device	CLASS II	Xpert MRSA recalled by Cepheid	Cepheid	Potency & Assay	24 states

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.