| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00628-1 |
| Product Name/Description |
ALBAclone Advanced Partial RhD Typing Kit. An in vitro diagnostic medical device (IVD)
Product Code: Z293
Lot Number: V174693
Expiry Date: 13 July 2017
ARTG Number: 225063 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
25/05/2017 |
| Responsible Entity |
|
| Reason/Issue |
The manufacturer has found that Lot No V174693 has a reduced level of performance associated with components H and L, which are generating weaker than normal reactions with some weak RhD and partial RhD samples. Reduced reactivity of components H and L is considered to make interpretation of the RhD variant sample type more difficult given results are available from only ten of the twelve monoclonal Anti-D cell lines contained in the kit. |
| Recall Action |
Recall |
| Recall Action Instructions |
Haemokinesis is advising users to quarantine and dispose of the affected lots. Haemokinesis will provide replacement stock or will issue a credit note. For previously generated results, the laboratory Medical Director should take into consideration the possible reduced reactivity of component H and L.
This action has been closed out on the 03/12/2018. |
| Contact Information |
03 9708 6299 - Haemokinesis |