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Terminated

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

FDA Recall Z-0376-2008 · Posted 2008-01-12

Recalling FirmCepheid
Recall StatusTerminated
Product CodeNJR
Date Initiated2007-09-05
Date Terminated2008-04-04
Product Quantity105

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)

Firm 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.

Root Cause

Release of Material/Component prior to receiving test results

Distribution Pattern

Worldwide Distribution

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K060540XPERT, GENEXPERT DX SYSTEMCepheid · 2006-07-25

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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