| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00441-1 |
| Product Name/Description |
Abtectcell III 0.8%, An in vitro diagnostic medical device (IVD)
Product number: 22450201
Lot number: 2245341
Expiry: 06/07/2024
ARTG 302034
(Immulab Pty Ltd - Reagent red blood cell IVDs) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
30/05/2024 |
| Responsible Entity |
|
| Reason/Issue |
Immulab has received reports of unexpected performance of Cell 3 (donor 4998548) Abtectcell III 0.8% batch 2245341, giving weaker than expected reactions with some examples of weak antibodies. Manufacturing preliminary investigation has confirmed the performance problem is specific to this batch only.
In a clinical laboratory there is the risk of overlooking the presence of clinically significant antibodies, potentially impacting compatibility between donor and recipient, which may lead to increased risk of incompatible blood transfusion.
|
| Recall Action |
Recall |
| Recall Action Instructions |
Immulab have prioritised manufacturing of the next batch of Abtectcell III 0.8% (2245342, exp 27/07/2024). Delivery of this batch will be completed to all customers by Wednesday the 5th of June 2024.
Customers are to:
- Cease use and quarantine affected stock.
- Immediately transition to use of the new batch 2245342 upon receipt.
- Consider reviewing patient samples that have been tested with batch 2245341, to ensure that weak antibodies have not been missed.
-Discard the quarantined batch.
In the interim while waiting for unaffected stock:
- Utilise alternative screening cells available (further instructions provided in the customer letter).
- Continue use of the prior batch 2245340, exp 04/06/2024. |
| Contact Information |
0418 315 961 - James Pistemalis Business Unit Manager - Immulab |