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Xpert EV Assay (2017-09-15)
- Starting date:
- September 15, 2017
- Posting date:
- October 6, 2017
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-64774
Affected products
Xpert EV Assay
Reason
High rate of invalid and probe check low (e5007) failures in the field when using GXEV-100N-10 lot 06802.
Affected products
Xpert EV Assay
Lot or serial number
Batch 1000045409 (Lot 06802)
Model or catalog number
07332940000097
Companies
- Manufacturer
-
CEPHEID
904 CARIBBEAN DRIVE
SUNNYVALE
94089
California
UNITED STATES