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BD MAX CT/GC/TV
- Starting date:
- August 11, 2017
- Posting date:
- September 8, 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-64458
Reason
Customers are reporting an increased rate of unresolved results (UNR) and indeterminate results (IND), which are higher than the rates claimed in the package insert.
Affected products
BD MAX CT/GC/TV
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
442970
Companies
- Manufacturer
-
Geneohm Sciences Canada, Inc.,
2555 Boul. Du Parc Technologique,
Québec
G1P 4S5
Quebec
CANADA