RegWardenFDA facility compliance records
Recall

Class III — Cepheid

Recalling firmCEPHEID
Registered facilityView this company's 3 registered facilities → (openFDA recall records do not name a specific facility)
ClassificationClass III
StatusTerminated
ReasonFirm 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.
ProductXpert CT/NG Urine Specimen Collection Kit Part number GXCT/NGURINE-50; Microbiology: Xpert CT/NG Urine Specimen Collection Kit is designed to preserve and transport Chlamydia trachomatis and Neisseria gonorrhoeae DNA in first-catch male and female urine specimens from symptomatic and asymptomatic individuals prior to analysis with the Cepheid Xpert CT/NG Assay.
Quantity1800 kits US, 31 ROW
DistributionWorldwide distribution. US nationwide, including North Mariana Islands, Aruba, Canada, Chile, Colombia, Costa Rica, Cyprus, Guam, Guatemala, Italy, Malawi, Micronesia Federated States, Panama, San Marino, South Africa, Spain, Switzerland, and Zimbabwe.
Initiated2015-07-27
Classified2015-08-20
Terminated2015-09-28
Recall numberZ-2432-2015
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class III recall — Cepheid (Z-2432-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/71841/

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