The Recall Desk

FDA (Devices) recall action 71841

Cepheid recalled 2 products on 2015-08-26

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2015-08-26
Critical
0
Units
—

Why these products were recalled

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.

The agency’s own wording, quoted from the enforcement report.

States named across these recalls

1–2 of 2

  • LowFDA (Devices)··2015-08-26

    Cepheid Recalls Xpert CT/NG Urine Specimen Collection Kits

    Cepheid is recalling Xpert CT/NG Urine Specimen Collection Kits because some lots contain a sub-component with an expiration date earlier than the kit's expiration date.

    Product
    Xpert 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 symptom
    Category
    Distribution
    1 state
  • LowFDA (Devices)··2015-08-26

    Cepheid Recalls Xpert CT/NG Vaginal and Endocervical Specimen Collection Kits

    Cepheid is recalling Xpert CT/NG Vaginal/Endocervical Specimen Collection Kits because some lots contain a sub-component with an earlier expiration date than the kit itself.

    Product
    Xpert CT /NG Vaginal/Endocervical/ Specimen Collection Kit: Part number CT/NGSWAB-50; Microbiology: The Cepheid X pert CT /NG Vagina Endocervical/ Specimen Collection Kit is designed to collect, preserve and transport patient Chlamydia trachomatis and Neisseria gonorrhoeae DN
    Category
    Distribution
    1 state