Cepheid, Xpert GBS Assay Diagnostic Test Kit Part No:… recallZ-0376-2008 · Cepheid · initiated Sep 5, 2007
Terminated All recalls posted in January 2008
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Cepheid or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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)
FDA root cause category: Release of Material/Component prior to receiving test results
What the company is doing
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.
Recall details
- Recall number
- Z-0376-2008
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Sep 5, 2007
- Posted by the FDA
- Jan 12, 2008
- Recalling firm
- Cepheid
- Quantity
- 105
- Product code
- NJR
- FDA submissions
- K060540
- Distribution
- Worldwide Distribution
Product description
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
Code information (models, lots, serial numbers)
Lot Number : 1402
Other devices under the same FDA submission
1 device cleared under K060540 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Xpert GBS GXGBS-100N-10Cepheid · Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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