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Mg2
- Starting date:
- July 3, 2017
- Posting date:
- August 14, 2017
- 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-64108
Reason
The Magnesium Gen 2 Assay (cat # 06407358190) may have low quality control recovery and frequent failed calibrations upon performing 2 points calibration when used on the Cobas C701-702 Analyzers after 7 days on board.
Affected products
Mg2
Lot or serial number
All lots
Model or catalog number
06407358190
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY