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Xpert EV (2016-04-04)
- Starting date:
- April 4, 2016
- Posting date:
- April 22, 2016
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- Healthcare Professionals, General Public, Hospitals
- Identification number:
- RA-58042
Affected products
A. Xpert EV
Reason
Some customers have experienced cartridge performance with a higher number of invalid results than would typically be expected with this test and its intended use specimen types.
Affected products
A. Xpert EV
Lot or serial number
1000030471
Model or catalog number
GXEV-100N-10
Companies
- Manufacturer
-
CEPHEID
904 CARIBBEAN DRIVE
SUNNYVALE
94089
California
UNITED STATES