Cepheid, Xpert GBS Assay Diagnostic Test Kit Part No: GXGBS-100N-10 (in foil pouch) for use with the GeneXpert DX System
FDA device recall Z-0376-2008 · posted 2008-01-12 · Terminated
Recall details
- Recalling firm
- Cepheid
- 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)
- Action taken
- 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
- Status
- Terminated
- Product code
- NJR
- Quantity affected
- 105
- Distribution
- Worldwide Distribution
- Date initiated
- 2007-09-05
- Date posted
- 2008-01-12
- Date terminated
- 2008-04-04
- Location
- Sunnyvale, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| XPERT, GENEXPERT DX SYSTEM (K060540) | Cepheid | 2006-07-25 |