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COBAS MIRA SYSTEM - LIPASE ASSAY (2015-07-02)
- Starting date:
- July 2, 2015
- Posting date:
- August 10, 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-54528
Affected Products
A. COBAS MIRA SYSTEM - LIPASE ASSAY
Reason
The manufacturer has identified that the Lipase Assay was showing occasionally calibration and QC failures associated to on-board reagent stability that have trigger the need to have the reagent shelf-life to be reduced from 15 to 9 months.
Affected products
A. COBAS MIRA SYSTEM - LIPASE ASSAY
Lot or serial number
All Lots
Model or catalog number
- 07041918190
- 11821792216
- 11821822216
Companies
- Manufacturer
-
Roche Diagnostics Gmbh
Sandhoferstrasse 116
Mannheim
68305
GERMANY