| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00031-1 |
| Product Name/Description |
BM Lactate Test Strips for use with the Accutrend Plus, Accutrend GC/GCT/Lactate. An in vitro diagnostic medical device (IVD)
All lots (2133260x, 2153300x, 2173380x) within shelf life are affected
Material Numbers: 3012654016 & 3012654370
ARTG Number: 201876
|
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
16/01/2013 |
| Responsible Entity |
|
| Reason/Issue |
The BM-Lactate test strips show a positive bias of 1.0 to 1.5 mmol/L with patient samples. |
| Recall Action |
Recall |
| Recall Action Instructions |
Roche Diagnostics Australia Pty Ltd is requesting that customers cease use and discard all lots of Accutrend BM-Lactate. |
| Contact Information |
1800 645 619 - Roche National Support Centre |