Cepheid

5 FDA enforcement actions

5 Total Recalls

0 Class I

5 Class II

0 Class III

Firm Details

Product Types: device
States: CA

All Recalls

Class II: Risk 11/05/2025 device

Product testing did not meet expected stability criteria.
Class II: Risk 10/30/2025 device

Invitro diagnostic test kits with specimens that have elevated white blood cell count (>30,000 cell) may cause inaccurate results.
Class II: Risk 10/30/2025 device

Invitro diagnostic test kits with specimens that have elevated white blood cell count (>30,000 cell) may cause inaccurate results.
Class II: Risk 08/06/2025 device

As a result of Post-Market half-time stability testing, false negative test result was observed for a positive sample type.
Class II: Risk 06/20/2024 device

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.

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.