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ALDOLASE MANUAL METHOD (2016-05-30)
- Starting date:
- May 30, 2016
- Posting date:
- June 13, 2016
- 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-58850
Affected products
A. ALDOLASE MANUAL METHOD
Reason
Customers using a Randox RX imola instrument only, will not be able use Randox Aldolase reagent (AD189) with the instrument specific application provided. The parameters shown on the screen shots on the instrument specific application sheet for Aldolase assay on the RX imola instrument are incorrect. The settings do not allow for absorbance change, therefore calibration is not possible, and the assay cannot be run as a test. Affected customers will receive an updated instrument specific application sheet for Aldolase with the correct parameters.
Affected products
A. ALDOLASE MANUAL METHOD
Lot or serial number
All lots
Model or catalog number
AD189
Companies
- Manufacturer
-
Randox Laboratories Ltd.
55 Diamond Road
Ardmore, County Antrim
BT29 4QY
UNITED KINGDOM