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KAPP2 & LAMB2 Tina-quants (2017-11-02)
- Starting date:
- November 2, 2017
- Posting date:
- November 22, 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-65200
Affected products
A. KAPP2 (TINA-QUANT KAPPA GEN.2 FOR ROCHE/HITACHI, MODULAR P AND COBAS C
B. LAMB2 (TINA-QUANT LAMBDA GEN.2 FOR COBAS C 311 AND COBAS C 501/502)
Reason
Internal investigations revealed an interference with lipemia and rheumatoid factors in the increased rerun mode for Tina-quant Kappa Gen.2 and Tina-quant Lambda Gen.2. As a consequence, the increased rerun function for both assays will be removed from the respective method sheets and the new values and new ratios will be changed in the next version of the method sheets.
Affected products
A. KAPP2 (TINA-QUANT KAPPA GEN.2 FOR ROCHE/HITACHI, MODULAR P AND COBAS C
Lot or serial number
All lots
Model or catalog number
6749976190
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY
B. LAMB2 (TINA-QUANT LAMBDA GEN.2 FOR COBAS C 311 AND COBAS C 501/502)
Lot or serial number
All lots
Model or catalog number
6749992190
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY