| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00209-1 |
| Product Name/Description |
Panocell – 10 Reagent Red Blood Cells. An in vitro diagnostic medical device (IVD)
Lot number: 03797
Reference number: 0003032
UDI-DI number: 10888234000396
Expiry date: 22 Mar 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 II |
| Recall Action Commencement Date |
20/03/2024 |
| Responsible Entity |
|
| Reason/Issue |
The manufacturer has identified an issue pertaining to P1 (P1PK1) antigen status for donor F1067, Cell 6. The donor is listed as P1– on the Master List. Further testing of the donor’s red blood cells has demonstrated reactivity with some examples of anti-P1.
Therefore, the donor has been recharacterised as P1+w. As noted on the Master List, an antigen designated with a “w” represents a weakened expression of the antigen that may not react with all examples of the corresponding antibody.
Specimens containing anti-P1 may demonstrate reactivity with Cell 6, leading to inaccurate test results.
No incidents have been reported to date. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
A corrected Master List for Panocell-10, lot 03797 will be provided and is identified with an “A” in the upper-left corner. Customers to replace original Master List with this corrected Master List.
Paragon Care Group Australia Pty also recommend customers to evaluate any potential impact on previous test results performed using Cell 6 (donor F1067) per customer's quality system policies/procedures. |
| Contact Information |
recalls@paragoncare.com.au - Paragon Care Group Australia |