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COBAS LIAT ANALYZER (2017-10-24)
- Starting date:
- October 24, 2017
- Posting date:
- November 24, 2017
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- Hospitals, General Public, Healthcare Professionals
- Identification number:
- RA-65172
Affected products
COBAS LIAT ANALYZER
Reason
A situation was identified where the cobas Liat analyzer was manufactured and distributed with 3 assay scripts pre-loaded on the instrument. One of the assay script (cobas Liat Strep A) is not yet licenced in Canada. However, there is no user-impact since the assay is not available in Canada and is not functional on the analyzer leading to no consequence on result reliability.
Affected products
COBAS LIAT ANALYZER
Lot or serial number
All lots
Model or catalog number
7341920190
Companies
- Manufacturer
-
Roche Molecular Systems Inc.
1080 US Highway 202
Branchburg
08876
UNITED STATES