| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00329-1 |
| Product Name/Description |
Monoclonal Mouse Anti-Human Leukaemia, Hairy Cell Clone DBA.44. An in vitro diagnostic medical device.
Code Number: M0880
Lot Numbers: 20033445 and 20042272
ARTG Number:183436
(Agilent Technologies Australia - Immunohistology cell marker IVDs) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
16/04/2018 |
| Responsible Entity |
|
| Reason/Issue |
It has been identified that the primary labels of the affected vials of M0880 were mislabelled with an incorrect concentration.
The concentration was written to be 187 mg/L. The correct concentration is 485 mg/L.
To date, no customer complaints have been received as a result of this issue. |
| Recall Action |
Recall |
| Recall Action Instructions |
Agilent Technologies is advising customers to discard any bottles of the affected lots of this product in line with the precautions outlined in the IFU. Agilent will provide replacement product to affected sites who hold unused or partially used vials.
Agilent Technologies is advising users who may have run results at an altered dilution due to the larger protein concentration and without appropriate run controls to review results and re-run where required.
This action has been closed out on the 21/11/2018. |
| Contact Information |
1800 802 402 - Agilent Technologies |