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Ethanol Gen.2 (EtOH2) For Cobas Integra and Cobas C Systems
- Starting date:
- March 14, 2017
- Posting date:
- April 4, 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-62900
Reason
The endogenous interferences for the ethanol assay were verified and it was found out that the lipemic interference up to an l index of 2000 could not be confirmed.
Affected products
Ethanol Gen.2 (EtOH2) For Cobas Integra and Cobas C Systems
Lot or serial number
19335201
20806301
22327901
Model or catalog number
03183777190
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY