| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00638-1 |
| Product Name/Description |
Red Blood Cell Antibody Identification Reagent - Phenocell C 0.8% and Phenocell C 3%. An in vitro diagnostic medical device (IVD).
Phenocell C 0.8%
Catalogue number: 96530201
Lot number: 9653 052
Phenocell C 3%
Catalogue number: 86640201
Lot number: 8664 052 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
28/06/2013 |
| Responsible Entity |
|
| Reason/Issue |
The Antigen Composition Sheet supplied with the product listed Cell 5 as Lu-a negative. However, a customer complaint was received from the IMVS Adelaide Red Cell Reference Laboratory that they typed Cell 5 as Lua positive. Confirmatory testing performed by bioCSL in response to the customer complaint has confirmed that Cell 5 does type as Lu-a positive (weak reaction – score 5 (0-12 scale)). |
| 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 IH Business Manager |