Fructosamine Calibrator, Control 1 and 3 (2018-12-09)
- Starting date:
- December 9, 2018
- Posting date:
- January 8, 2019
- 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-68678
Affected products
- Fructosamine Calibrator
- Fructosamine Control 1
- Fructosamine Control 3
Reason
Randox is conducting a Device Modification for Fructosamine Calibrator, Fructosamine Control 1 and Control 3 for the lots specified. The assigned value of Fructosamine in this calibrator and controls has now been re-assigned 25% lower.
Affected products
A. Fructosamine Calibrator
Lot or serial number
-
498FR
Model or catalog number
-
FR2993
Companies
- Manufacturer
-
Randox Laboratories Ltd.
55 Diamond Road
Crumlin, County Antrim
BT29 4QY
UNITED KINGDOM
B. Fructosamine Control 1
Lot or serial number
499FR
Model or catalog number
FR2994
Companies
- Manufacturer
-
Randox Laboratories Ltd.
55 Diamond Road
Crumlin, County Antrim
BT29 4QY
UNITED KINGDOM
C. Fructosamine Control 3
Lot or serial number
500FR
Model or catalog number
FR2996
Companies
- Manufacturer
-
Randox Laboratories Ltd.
55 Diamond Road
Crumlin, County Antrim
BT29 4QY
UNITED KINGDOM