| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00249-1 |
| Product Name/Description |
BD HLA-B27 Kit (An in vitro diagnostic medical device (IVD))
Catalogue Number: 340183
Unit: Kit
Lot Number: 3029914
ARTG Number: 192529 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
19/03/2013 |
| Responsible Entity |
|
| Reason/Issue |
The HLA-B27 FITC/CD3 PE reagent in the BD HLA-B27 Kits is contaminated with CD4 PE. This results in an apparent elevated cell population. |
| Recall Action |
Recall |
| Recall Action Instructions |
Laboratories are requested to discard all remaining stock from the affected lot of HLA-B27 kit.If the affected lot has been used, laboratories are requested to review and examine all data files for possible incorrect CD3 staining due to the contamination with CD4. Unless confirmatory testing has already been conducted, positive samples should be tested using an alternative method. |
| Contact Information |
02 8875 7045 - Becton Dickinson |