| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00829-1 |
| Product Name/Description |
Phenocell C 0.8% and Phenocell C 3%. An in vitro diagnostic medical device (IVD)
Phenocell C 0.8%
Lot number: 9653 054
Phenocell C 3%
Lot number: 8664 054
|
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
5/08/2013 |
| Responsible Entity |
|
| Reason/Issue |
bioCSL carried out confirmatory testing on all products potentially supplied with incorrect phenotype information ie, donor 1 was Lu-a positive whereas the Antigen Composition sheet stated donor 1 as Lu-a negative. In addition to confirming the Lu-a inconsistency, testing identified that the donor was Co(b) positive whereas the Antigen Composition Sheet indicated donor as Co(b) negative. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
bioCSL is providing end users with an updated Antigen Composition Sheets for affected kits. The updated information is also provided online at www.biocsl.com.au/IH |
| Contact Information |
03 9389 1000 - bioCSL Immuno Haematology |