Recall Z-2432-2015— Cepheid

Name: FDA recall Z-2432-2015
Creator: U.S. Food and Drug Administration
Published: 2015-07-27

Class III · Terminated

Class III FDA medical device recall by Cepheid, initiated 2015-07-27, terminated 2015-09-28. It names one FDA 510(k) clearance: K121710. 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 symptomatic and asymptomatic individuals prior to analysis with the Cepheid Xpert CT/NG Assay.. Reason: 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..

Recalling firm: Cepheid
Classification: Class III
Status: Terminated
Initiated: 2015-07-27
Terminated: 2015-09-28
Firm location: Sunnyvale, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K121710 — XPERT CT/NGCepheid·cleared 2012-12-27

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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 symptomatic and asymptomatic individuals prior to analysis with the Cepheid Xpert CT/NG Assay.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.