| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-01071-1 |
| Product Name/Description |
BacT/ALERT 3D B.40.xx Firmware (Automated blood culture incubator/growth detector). An in vitro diagnostic medical device (IVD)
Product code: 411814 or 411818 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
22/10/2012 |
| Responsible Entity |
|
| Reason/Issue |
An improper load occurs when the user performs another action (such as loading a bottle or scanning another bottle) before the reply beeps have been issued. An improper load results in the first bottle not being recognised as being loaded in the instrument and the second bottle's readings being incorrectly reported in association with the first bottle. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Affected laboratories are to implement the corrected User Manual provided by the Sponsor. |
| Contact Information |
1800 333 421 - Technical assistance |