| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-01103-1 |
| Product Name/Description |
Tina-quant Albumin. An in vitro diagnostic medical device (IVD)
Material Number: 04999622190
Lot Number: 60221401
ARTG Number: 174908 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
11/11/2015 |
| Responsible Entity |
|
| Reason/Issue |
Roche Diagnostics is recalling one lot of Tina-quant albumin (used for the determination of specific proteins in samples) following advice that it may show an elevated QC recovery outside of specification when used on the Modular P analyser.
This phenomenon is only noted when using Roche QC Precinorm PUC (Material Number 03121313122). |
| Recall Action |
Recall |
| Recall Action Instructions |
Roche is advising users to inspect stock and discard all units of the affected lot number. Affected stock will be replaced by alternative lots which are unaffected by this issue. This action has been closed-out on 29/08/2016. |
| Contact Information |
02 9860 2357 - Roche Diagnostics |