| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00118-1 |
| Product Name/Description |
Panocell 16 and Panocell 20. An in vitro diagnostic medical device (IVD).
Panocell 16
Seqirus Product Item: 2332
Pack Size: 1 kit (16 cell panel)
Lot Number: 39330
Expiry Date: 04/12/2015
Panocell 20
Seqirus Product Item: 5020
Pack Size: 1 kit (20 cell panel)
Lot Number: 47436 (expiry 29/01/2016), 23160 (expiry 14/08/2015), 14052 (expiry 12/06/15)
ARTG Number: 245555 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
1/02/2016 |
| Responsible Entity |
|
| Reason/Issue |
Reports have been received concerning unexpected positive reactivity when testing donor N3512 with anti-V.
Donor N3512 was listed as V– (negative) on the Master List supplied with these products. Immucor have confirmed that this donor is V+ (positive). |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Seqirus is providing a revised master list which correctly identifies Donor N3512 as V+ (positive). Seqirus is asking users to evaluate the impact the amended phenotype information may have on results generated with these product lots as per the users' procedures. This action has been closed-out on 04/05/2017. |
| Contact Information |
03 9389 4987 - Seqirus |