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Liquid Urine Control Level 3
- Starting date:
- April 20, 2017
- Posting date:
- June 5, 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-63478
Reason
Randox has identified a labelling error for 2 of the test methods listed for quantification of total protein (urine). The values for the mean of all instruments are incorrect by a factor of 10. This does not affect the performance or stability claims of the product. Instrument specific values are correct.
Affected products
Liquid Urine Control Level 3
Lot or serial number
907UC
Model or catalog number
UC5075
Companies
- Manufacturer
-
Randox Laboratories Ltd.
55 Diamond Road
Ardmore, County Antrim
BT29 4QY
UNITED KINGDOM