| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-01020-1 |
| Product Name/Description |
Grifols Australia Perfect Panel cells
Product Codes: 904114, 904125, 904114L, 904125L, 904114T
Set Lot Numbers: 904114.04.2, 904125.04.2, 904114L.04.2, 904125L.04.2 and 904114T.73.1
Expiry date: 17/11/2014
ARTG number: 178738 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
24/09/2014 |
| Responsible Entity |
|
| Reason/Issue |
Grifols Australia wishes to advise of an error identified on the Antigen Composition Sheet for Perfect Panel.
The Antigen Composition Sheet supplied with the affected lots of product states Cell No. 6 as Donor no.154. The Antigen Composition Sheet should state Cell No. 6 as Donor no. 213 and the corresponding phenotypic profile. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Grifols Australia is providing their customers with the correct Antigen Composition Sheet with the recall action correspondence. This action has been closed-out on 06/06/2016. |
| Contact Information |
03 9535 9333 - Grifols Australia Pty Ltd |