| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00004-1 |
| Product Name/Description |
BBL Crystal Enteric/Non-fermenter ID Kit, An in vitro diagnostic medical device (IVD)
Catalogue number: 245000
Lot number: 2129487
Expiration date: 13 March 2013
|
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
8/01/2013 |
| Responsible Entity |
|
| Reason/Issue |
Becton Dickinson has determined that these products have the citrate (CIT) and malonic acid (MLO) reagents in the reversed prong/well positions. This may lead to no-identification or multiple identification choices. Customers specifically reported split identification results between Citrobacter and Salmonella, however other bacterial identifications requiring the use of these two substrates may be affected. |
| Recall Action |
Recall |
| Recall Action Instructions |
Becton Dickinson Pty Ltd is advising customers to discontinue use and discard any affected product. Replacement product or credit will be provided for any discarded product. |
| Contact Information |
02 8875 7045 - Becton Dickinson Regulatory Affairs |