Homocysteine Calibrator (2018-02-22)
- Starting date:
- February 22, 2018
- Posting date:
- March 13, 2018
- 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-66132
Affected products
HOMOCYSTEINE CALIBRATOR
Reason
The Homocysteine Calibrator Kit may cause up to 20% higher recoveries in quality control and patient samples. False results are detected in the control but may cause delay in obtaining results.
Affected products
HOMOCYSTEINE CALIBRATOR
Lot or serial number
235108
Model or catalog number
5385504190
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY