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COBAS KRAS MUTATION TEST (2015-06-16)
- Starting date:
- June 16, 2015
- Posting date:
- July 8, 2015
- 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-54100
Recalled Product
- COBAS KRAS MUTATION TEST
Reason
Following the routine stability monitoring, the cobas KRAS Mutation Test (cat # 05852170190, lot t15475) was identified to be generating invalid results for the mutant control and/or KRAS calibrator at a much higher rate than expected.
Affected products
A. COBAS KRAS MUTATION TEST
Lot or serial number
T15475
Model or catalog number
05852170190
Companies
- Manufacturer
-
Roche Diagnostics Gmbh
Sandhoferstrasse 116
Mannheim
68305
GERMANY