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IGG-2(TINA-QUANT IGG GEN.2) FOR USE ON C701 ANALYZER (2017-10-10)
- Starting date:
- October 10, 2017
- Posting date:
- October 27, 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-64950
Affected products
IGG-2(TINA-QUANT IGG GEN.2) FOR USE ON C701 ANALYZER
Reason
Following internal investigation, the manufacturer identified a situation where the specifications for QC recoveries could not be fulfilled for the sensitive applications (urine/CSF) for the Tina-Quant IgG Gen-2 assay (cat #05220718190 lot 26358701) on cobas c701-702 analyzers. This situation has no impact in Canada since the identified lot will not be distributed to users.
Affected products
IGG-2(TINA-QUANT IGG GEN.2) FOR USE ON C701 ANALYZER
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
5220718190
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY