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COBAS INTEGRA Rheumatoid Factors II (RF-II)
- Starting date:
- December 1, 2016
- Posting date:
- January 6, 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-61566
Reason
This recall/product correction is related to potential calibration failure, low quality control recovery and frequent zero results on patient samples for specific lots of Rheumatoidfactors II used on Roche Cobas Integra and/or Cobas C platforms.
Affected products
COBAS INTEGRA Rheumatoid Factors II (RF-II)
Lot or serial number
60855801
61109601
61835301
Model or catalog number
20764574322
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY