Z-0592-2018Class II

Xpert CT/NG Catalog GXCT/NG-120 Batch 1000049568, Catalog GXCT/NG-10 Batch 1000053075, Catalog GXCT/NG-10...

Name: Z-0592-2018 Xpert CT/NG Catalog GXCT/NG-120 Batch 1000049568, Catalog GXCT/NG-10 Batch 1000053075, Catalog GXCT/NG-10...
Creator: Cepheid
Published: 2017-10-09
License: https://open.fda.gov/license/

Cepheid / initiated 2017-10-09 / Terminated / root cause: manufacturing process

FDA source

Cepheid began a recall of Xpert CT/NG Catalog GXCT/NG-120 Batch 1000049568, Catalog GXCT/NG-10 Batch 1000053075, Catalog GXCT/NG-10 Batch 1000056156 and Catalog GXCT/NG-10 Batch... on 2017-10-09. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0592-2018
Classification: Class II
Status: Terminated
Initiated: 2017-10-09
Posted: 2018-02-12
Terminated: 2018-02-13
Recalling firm: Cepheid
Product: Xpert CT/NG Catalog GXCT/NG-120 Batch 1000049568, Catalog GXCT/NG-10 Batch 1000053075, Catalog GXCT/NG-10 Batch 1000056156 and Catalog GXCT/NG-10 Batch 1000056157. Is a qualitative in vitro real-time PCR test.
Product code: LSL Dna-Reagents, Neisseria
Reason for recall: 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 false negative results which remains consistent with package insert claims.
Root cause tag: manufacturing process
FDA root cause: Equipment maintenance
Action: An Urgent Medical Device Recall letter (response form included), dated October 9, 2017, was sent to affected consignees. The letter identified the affected product, the issue involved, impact, and actions to be taken. Cepheid will provide replacement product for Xpert CT/NG assay product identified in this recall. Customers are to complete and the return the Response Form provided in order to receive replacement product. Additionally, the letter instructs users to review their laboratory statistics to see if their positivity rates are trending low during use of the affected lots. If so, they are to review the negative patient results according to their laboratory's Quality Management System. Customers are to refer to the applicable contact information provided if there are any questions.
Quantity in commerce: 3,586 kits (49,400 units)
Distribution: Worldwide Distribution -- USA, Puerto Rico, and Haiti.
Product codes and lots: Lot numbers: 25718, 25719, 25725, and 25727.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0592-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0592-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-21	2018-02-12

Product code LSL

K121710Class IIXpert Ct/ngCepheid / cleared 2012-12-27

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)