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HOMOCYSTEINE TESTS (2015-03-27)
- Starting date:
- March 27, 2015
- Posting date:
- April 27, 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-53097
Recalled Products
A. HOMOCYSTEINE TESTS
Reason
This recall is related to a potential under recovery of specific lots of homocysteine in EDTA plasma samples. Serum samples are not affected by this issue.
Affected products
A. HOMOCYSTEINE TESTS
Lot or serial number
- 69781101 (Model 05385815190)
- 69781401 (Model 06542921190)
Model or catalog number
- 05385415190
- 06542921190
Companies
- Manufacturer
-
Roche Diagnostics Gmbh
Sandhoferstrasse 116
Mannheim
68305
GERMANY