| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00229-1 |
| Product Name/Description |
Cobas c 501 / c 502 and COBAS INTEGRA. An in vitro diagnostic medical device (IVD)
Material Number: 05 385 415 190
Affected lots: 69781101
Expiry Date: 30 Apr 2015
Subsequent lots: 60717101
Expiry Date: 31 Jan 2016 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
17/03/2015 |
| Responsible Entity |
|
| Reason/Issue |
Following customer complaints regarding a 20% decrease in control levels when using third party controls (e.g. ThermoFisher LiqImmune) Roche has identified that reagent lot 697811 shows a negative bias of up to 54% compared to lot 604303.This negative bias could, in the worst case, lead to inaccurately low Homocysteine results.
This issue only occurs with EDTA plasma samples. |
| Recall Action |
Recall |
| Recall Action Instructions |
Roche is requesting their customers to discard any remaining units from the affected lot. This action has been closed-out on 18/08/2016. |
| Contact Information |
1800 645 619 - Roche Diagnostics National Support Centre |