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
- Company
- Cepheid
- Recall Initiated
- September 5, 2007
- Posted
- January 12, 2008
- Terminated
- April 4, 2008
- Recall Number
- Z-0376-2008
- Quantity
- 105
- Firm Location
- Sunnyvale, CA
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)
Distribution
Worldwide Distribution
Lot / Code Info
Lot Number : 1402
Root Cause
Release of Material/Component prior to receiving test results
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.
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