| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00534-1 |
| Product Name/Description |
Panocell – 10 Reagent Red Blood Cells. An in vitro diagnostic medical device (IVD)
Product number: IMM0003032
Lot number: 21934/21934A
Expiry date: 26/07/2024
ARTG 245555
(Paragon Care Group Australia Pty Ltd trading as Immulab - Reagent red blood cell IVDs) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
28/06/2024 |
| Responsible Entity |
|
| Reason/Issue |
Immucor has detected that some kits of Panocell-10 exhibit an unexpected dark colour (haemolysis) and darkening of the red blood cells. Fungal growth has been confirmed in the vials where the haemolysis and darkening of the red blood cells has been observed. |
| Recall Action |
Recall |
| Recall Action Instructions |
If current Panocell vials are exhibiting an unexpected dark colour (haemolysis) and/or darkening of the red blood cells, do not use the vials and contact ParagonCare for replacement product.
Evaluate any impact on previous test results as required by procedures.
Previous test results may be considered valid provided that:
· the vial(s) of Panocell used in testing were not discoloured, and
· the quality controls described in the Quality Control section of the Instructions for Use (IFU)/package insert were performed and the results were acceptable. |
| Contact Information |
0458 315 961 - James Pistemalis, Business Unit Manager - Immulab |