| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-01295-1 |
| Product Name/Description |
Urinary Catecholamines by HPLC Reagent Kits, Automated Method on Gilson ASPEC. An in vitro diagnostic medical device (IVD)
Catalogue Number: 1955700 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
24/12/2012 |
| Responsible Entity |
|
| Reason/Issue |
There is a risk of false negative results being reported in urine samples; the concentration of adrenaline/epinephrine may decrease when analysis time is more than 8 hours. This occurs when the samples are subsequently adjusted to pH 5 to 7 as described in the instructions for use for very acidic samples or samples with low 24-volumes |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
The sponsor is providing an update to the Instructions for Use (IFU). |
| Contact Information |
1800 224 354 - Bio-Rad Laboratories |