RegWardenFDA facility compliance records
Company

CEPHEID

9 recall(s) on record — most severe on record: Class II.

Recalls by year

FDA actions on record by year2015: 1 recalls; 2016: 1 recalls; 2017: 2 recalls; 2023: 1 recalls; 2024: 1 recalls; 2025: 3 recalls120151201622017201820192020202120221202312024320252026
  • Recalls (9)

Registered facilities (3)

Recalls & enforcement

  • Class IIOngoing2025-11-05
    Product testing did not meet expected stability criteria.
  • Class IIOngoing2025-10-30
    Invitro diagnostic test kits with specimens that have elevated white blood cell count (>30,000 cell) may cause inaccurate results.
  • Class IIOngoing2025-08-06
    As a result of Post-Market half-time stability testing, false negative test result was observed for a positive sample type.
  • Class IIOngoing2024-06-20
    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 IIOngoing2023-04-24
    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 IITerminated2017-10-09
    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 …
  • Class IITerminated2017-09-15
    Customers have reported a higher than expected number of invalid test results when using the recalled product per the package insert.
  • Class IITerminated2016-07-18
    Internal investigation found the certain lots of MRSA kits have the potential for performance issues at lower positive sample concentrations.
  • Class IIITerminated2015-07-27
    Firm determined that some lots of CT/NG Swab 50 and CT/NG Urine collection kits contain a sub component with an expiry date that is earlier than the kit expiration date.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “CEPHEID — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-9062742-cepheid/

Not open yet

Alerts for CEPHEID

Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.

Planned

Want a one-page facility brief?

A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.