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Csf Control
- Starting date:
- July 20, 2017
- Posting date:
- September 11, 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-64480
Reason
The value for IgG on the insert for 107CF quoted the target as mg/L instead of mg/dL. This does not affect the performance or stability claims of the product.
Affected products
Csf Control
Lot or serial number
107CF
Model or catalog number
RDX-CF1500
Companies
- Manufacturer
-
Randox Laboratories Ltd.
55 Diamond Road
Ardmore, County Antrim
BT29 4QY
UNITED KINGDOM