| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-01330-1 |
| Product Name/Description |
FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor Clone EP1, Ready-to-use. An in vitro diagnostic medical device (IVD).
Code Number: GA084
Lot Number: 10125849
Expiry: 31 March 2018
ARTG Number: 183436
(Agilent Technologies Australia Pty Ltd - Immunohistology cell marker IVDs) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
31/10/2017 |
| Responsible Entity |
|
| Reason/Issue |
Agilent has determined that a specific lot of FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor Clone EP1 has shown weak non-specific nuclear and cytoplasmic / stomal staining in known negative samples. In this affected lot some, but not all, breast cancer samples will show weak false-positive staining in some nuclei. This could result in a false-positive result in patient tissue and may not be detected by run controls.
To date, Agilent has not received any customer complaints regarding this issue. |
| Recall Action |
Recall |
| Recall Action Instructions |
Agilent Technologies is advising users to discard affected Ready-to-Use GA084 vials from the affected lots. The vials should be discarded in accordance with the precautions in the Instructions For Use. Agilent will be providing affected users with replacement product in lieu of GA084. Laboratory Managers should review assay runs and patient results where the affected lots were used.
This action has been closed out on 30/10/2018 |
| Contact Information |
1800 802 402 - Agilent Technologies Australia |