| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00986-1 |
| Product Name/Description |
Phenocell A 3%. An in vitro diagnostic medical device (IVD).
Item Number: 06640201
Lot Number: 0664933
Expiry: 29/09/2014
ARTG: 223867 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
12/09/2014 |
| Responsible Entity |
|
| Reason/Issue |
A phenotyping error has been identified on the Antigen Composition Sheet supplied with Phenocel A, Lot 0664933. The error relates to the Colton b (Cob) phenotype listed for Cell 9. The Antigen composition Sheet supplied with these products stated Cell 9 as Cob negative. A complaint received by bioCSL reported that Cell Number 9 was confirmed to be positive (Cob+). |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
bioCSL is providing affected customers with an amended Antigen Composition Sheet for Phenocell A 3% Lot 0664933 which must replace the original Antigen Composition sheet. This amended Antigen Composition Sheet is also available for download via the Customer Service Portal login section on bioCSL's website: www.biocsl.com.au/IH. This action has been closed-out on 02/05/2017. |
| Contact Information |
03 9389 2000 - bioCSL |