| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00159-1 |
| Product Name/Description |
Lysercell WDF 2 x 4L used on Sysmex XN-Series Automated Haematology Analysers. An in vitro diagnostic medical device (IVD).
Material Number: 06510221001
Lot Numbers: A6028, A6029, A6030
ARTG Number: 188498 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
1/02/2017 |
| Responsible Entity |
|
| Reason/Issue |
Roche Diagnostics Australia has received several reports that Lysercell WDF 2 x 4L lots A6028, A6029 and A6030 can lead to an increased occurrence (up to 3-fold) of the flag “Blast/Abn Lympho?” . No other flags have been observed. This issue leads to an increase in the “Blast/Abn Lympho?” flagging rate and unnecessary manual review. The risk of a misdiagnosis is mitigated by the fact that any flags observed from the affected instruments must be confirmed by a qualified morphologist using a manual blood film. |
| Recall Action |
Recall |
| Recall Action Instructions |
Roche is advising customers to immediately discontinue use of and quarantine affected lots. New replacement lots will be provided by Roche.
This action has been closed-out on 21/03/2018. |
| Contact Information |
02 9860 2357 - Roche Diagnostics Australia |