| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00416-1 |
| Product Name/Description |
Dynabeads HLA (Human Leucocyte Antigen) Class II (an in vitro diagnostic medical device)
(reagent used for the isolation of HLA Class II+ cells from human peripheral blood)
Catalogue Number: 21004D
Lot Numbers:
135384110 (Expiry Date: 09/2014)
142281200 (Expiry Date: 02/2015)
ARTG Number: 212748 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
8/04/2014 |
| Responsible Entity |
|
| Reason/Issue |
The manufacturer of Dynabeads HLA Class II, Life Technologies AS, advises that the listed lots have decreased antibody performance and may not isolate sufficient levels of HLA Class II cells required for further testing. Lot 142281200 is still within specification, however testing has indicated that it might lose reactivity prior to its expiry date. |
| Recall Action |
Recall |
| Recall Action Instructions |
Life Technologies is requesting their customers to inspect their stock and dispose of all units from the affected lots. Lot 142281200 can continue to be used until replacement stock is available. |
| Contact Information |
1800 636 327 - Life Technologies Australia Pty Ltd |