Xpert GBS Assay (2017-12-08)
- Starting date:
- December 8, 2017
- Posting date:
- February 1, 2018
- 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-65864
Affected products
Xpert GBS Assay
Reason
High number of pressure abort (E2008) errors observed in the field when using GXGBS-100N-10 lots 08006, 08007, 08008, 08009, 08010, 08011, 08012, 08401, 08402, 08403, 08404, 08405, 08406, 08407, 08408, 08409, 08410, 09201, and 09202.
Affected products
Xpert GBS Assay
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
GXGBS-100N-10
Companies
- Manufacturer
-
Cepheid
904 Caribbean Drive
Sunnyvale
94089
California
UNITED STATES