| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00331-1 |
| Product Name/Description |
Dako Beta-2-Microglobulin PET Kits. An in vitro diagnostic medical device (IVD)
Product code: K0052
Lot Number: 20012249
ARTG number: 200116 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
14/04/2015 |
| Responsible Entity |
|
| Reason/Issue |
There is a stability issue with a single component of the kit, Vial 1 Beta-2-microglobulin Immunoparticles. Investigations have shown that a change in the pH value in the Beta-2-microglobulin Immunoparticles (Vial 1) has occurred resulting in low or no signal for the 2 lowest standards in the calibration curve. The identified change in the pH value may affect the accuracy of Beta-2-microglobulin values/results obtained, without any warnings from instruments. The Beta-2-microglobulin values may be measured up to 20% higher for samples in the clinically elevated ranges. |
| Recall Action |
Recall |
| Recall Action Instructions |
ELITech Group is advising users to cease use of the affected lot and discard any remaining inventory. This action has been closed-out on 18/07/2016. |
| Contact Information |
1800 815 098 - ELITechGroup Australia |