| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00951-1 |
| Product Name/Description |
Phenocell A 3%. An in vitro diagnostic medical device (IVD).
Serial Number: 06640201
Lot Number: 0664932
AUST I Number: 223867 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
5/09/2014 |
| Responsible Entity |
|
| Reason/Issue |
A phenotyping error has been identified on the Antigen Composition Sheet supplied with Phenocel A Lot 0664932. The error relates to the Colton b (Cob) phenotype listed for Cell 3. The Antigen composition Sheet supplied with these products stated Cell 3 as Cob positive. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
The affected lot has expired on the 01/09/2014. bioCSL is notifying their customers of the incorrect information on the antigen information sheets and is advising that the need review of results should be determined at the discretion of the laboratory or clinical director. This action has been closed-out on 06/06/2016. |
| Contact Information |
03 9389 2000 - bioCSL Australia Pty Ltd |