| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01323-1 |
| Product Name/Description |
ALBAclone Advanced Partial RhD Typing Kit. An in vitro diagnostic medical device (IVD).
Product Code: Z293
Affected Lot Numbers:
V163020, expiry 11 Aug 2017
V157640, expiry 9 Mar 2017
ARTG Number: 225063 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
13/10/2016 |
| Responsible Entity |
|
| Reason/Issue |
The shelf life of two lots of the ALBAclone Advanced Partial RhD Typing Kit has been reduced from 24 months to 12 months based on stability testing results for component L (Anti-D Cell Line LHM57/17). The revised shelf life for each of these lots of kit has now expired and the kits are being recalled. |
| 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 L.
This action has been closed out on 31/10/2018 |
| Contact Information |
03 9708 6299 - Haemokinesis |