| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00464-1 |
| Product Name/Description |
Immucor - Panocell -10 Reagent Red Blood Cells. An in vitro diagnostic medical device (IVD).
Lot Number: 17905
Expiry: 28/06/2024
REF: IMM0003032
UDI: 10888234000396
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 |
13/06/2024 |
| Responsible Entity |
|
| Reason/Issue |
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.
Fungal contamination may lead to erroneous results. |
| 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.
Customers are to 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.
The IFU precautions state: Reagent red blood cells should not be used if the cells darken, spontaneously clump or if there is significant haemolysis. Slight haemolysis may occur with age. Discard if markedly haemolyzed. |
| Contact Information |
0458 315 961 - James Pistemalis, Immulab |