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TQ D-DIMERS (2015-04-28)
- Starting date:
- April 28, 2015
- Posting date:
- May 21, 2015
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-53387
Recalled Products
- TQ D-DIMER GEN.2 COBAS C, INTEGRA
- TQ D-DIMER - MODULAR P
- TQ D-DIMER GEN.2 COBAS C 111
- TQ D-DIMER - COBAS C 701
Reason
There is a potential for falsely increased results on the D-Dimer Gen.2 Assay caused by specific immunoglobulins.
Affected products
A. TQ D-DIMER GEN.2 COBAS C, INTEGRA
Lot or serial number
All lots.
Model or catalog number
04912551190
Companies
- Manufacturer
-
Roche Diagnostics Gmbh
Sandhoferstrasse 116
Mannheim
68305
GERMANY
B. TQ D-DIMER - MODULAR P
Lot or serial number
All lots.
Model or catalog number
4912497190
Companies
- Manufacturer
-
Roche Diagnostics Gmbh
Sandhoferstrasse 116
Mannheim
68305
GERMANY
C. TQ D-DIMER GEN.2 COBAS C 111
Lot or serial number
All lots.
Model or catalog number
5077753190
Companies
- Manufacturer
-
Roche Diagnostics Gmbh
Sandhoferstrasse 116
Mannheim
68305
GERMANY
D. TQ D-DIMER - COBAS C 701
Lot or serial number
All lots.
Model or catalog number
5172381190
Companies
- Manufacturer
-
Roche Diagnostics Gmbh
Sandhoferstrasse 116
Mannheim
68305
GERMANY