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Xpert FLU/RSV XC (2016-04-11)
- Starting date:
- April 11, 2016
- Posting date:
- April 29, 2016
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-58162
Affected Products
Xpert FLU/RSV XC
Reason
Seven customers reported cartridge performance with a higher number of invalid results than would typically be expected with the kit and its intended use specimen types. Cepheid investigated the complaints and found that the complaints were valid. The failure investigation identifies six kit lots that were affected. Only one of the lots were imported and sold in Canada.
Affected products
Xpert FLU/RSV XC
Lot or serial number
1000023147
Model or catalog number
GXFLU/RSV-10
Companies
- Manufacturer
-
CEPHEID
904 CARIBBEAN DRIVE
SUNNYVALE
94089
California
UNITED STATES