Z-0376-2008

Cepheid, Xpert GBS Assay Diagnostic Test Kit Part No: GXGBS-100N-10 (in foil pouch) for use with the...

Name: Z-0376-2008 Cepheid, Xpert GBS Assay Diagnostic Test Kit Part No: GXGBS-100N-10 (in foil pouch) for use with the...
Creator: Cepheid
Published: 2007-09-05
License: https://open.fda.gov/license/

Cepheid / initiated 2007-09-05 / Terminated / root cause: labeling and UDI

FDA source

Cepheid began a recall of Cepheid, Xpert GBS Assay Diagnostic Test Kit Part No: GXGBS-100N-10 (in foil pouch) for use with the GeneXpert DX System, Cepheid, Sunnyvale, CA 94089 on 2007-09-05. The reason FDA records is "Labeling Error: Some cartridges may be mislabeled as "Xpert EV" instead of "Xpert GBS". (The information embedded in the barcode label on the cartridge is correct for Xpert GBS and brings up the GBS assay definition...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0376-2008
Status: Terminated
Initiated: 2007-09-05
Posted: 2008-01-12
Terminated: 2008-04-04
Recalling firm: Cepheid
Product: Cepheid, Xpert GBS Assay Diagnostic Test Kit Part No: GXGBS-100N-10 (in foil pouch) for use with the GeneXpert DX System, Cepheid, Sunnyvale, CA 94089
Product code: NJR Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test
Reason for recall: Labeling Error: Some cartridges may be mislabeled as "Xpert EV" instead of "Xpert GBS". (The information embedded in the barcode label on the cartridge is correct for Xpert GBS and brings up the GBS assay definition file)
Root cause tag: labeling and UDI
FDA root cause: Release of Material/Component prior to receiving test results
Action: Consignees were sent a Correction and Removal letter on 09/04/2007, notifying them that there was a labeling error with some of the cartridges labels indicating Xpert EV instead of Xpert GBS on the cartridge label. They are asked to discontinue using it immediately and return to Cepheid.
Quantity in commerce: 105
Distribution: Worldwide Distribution
Product codes and lots: Lot Number : 1402

Product code NJR

K060540Class IXpert, Genexpert Dx SystemCepheid / cleared 2006-07-25

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)