| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-01145-1 |
| Product Name/Description |
AHG Control Cells 3%. An in vitro diagnostic medical device (IVD)
Item Number: 01901371
Lot Number: 019075101
Expiry Date: 18/12/2015
ARTG Number: 224614 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
24/11/2015 |
| Responsible Entity |
|
| Reason/Issue |
There is an issue with the AHG Control Cells not testing as expected. It is giving very weak positive reactions when it should be giving a strong reaction when validating Antiglobulin tests.
IH Production has determined that the product was not formulated correctly, as the trial pool of the Anti-Rh Sensitising Reagent and the bulk were not made to the same strength due to operator error. This has resulted in the bulk Anti-Rh Sensitising Reagent being made 10 x weaker than the trial pool. This weak batch was used for formulating the AHG Control Cells. |
| Recall Action |
Recall |
| Recall Action Instructions |
The sponsor Seqirus is advising customers to inspect stock and quarantine all affected units prior to their return to the sponsor. The sponsor will arrange the replacement of the affected products or credit the account. This action has been clsoed-out on 29/08/2016. |
| Contact Information |
1800 008 275 - Seqirus Customer Service |