Optilite Beta-2-microglobulin Urine Kit (2018-03-09)
- Starting date:
- March 9, 2018
- Posting date:
- April 3, 2018
- 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-66328
Affected products
OPTILITE BETA-2 MICROGLOBULIN URINE KIT
Reason
Following an external complaint, investigations were reviewed on the 26/02/2018 and concluded the antigen excess protection of the assay at the initial dilution is only up to 18.4 mg/L (doc. 1 IFU). This does not meet the antigen excess protection (760 mg/L) stated in the IFU.
Affected products
OPTILITE BETA-2 MICROGLOBULIN URINE KIT
Lot or serial number
407459
Model or catalog number
LK043.L.OPT
Companies
- Manufacturer
-
The Binding Site Group Limited
8 Calthorpe Road
Birmingham
B15 1QT
UNITED KINGDOM