| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00857-1 |
| Product Name/Description |
BactiDrop Acridine Orange. An in vitro diagnostic medical device (IVD)
Item number: R21502
Batch number: 733100
ARTG 235680
(Thermo Fisher Scientific Australia Pty Ltd - Microbial-isolate identification and testing IVDs) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
30/09/2024 |
| Responsible Entity |
|
| Reason/Issue |
An internal technical investigation confirmed that BactiDrop Acridine Orange PK/50 R21502 lot 733100 may demonstrate a colour change of the solution within the dropper from orange-yellow to light yellow, which may result in out of specification fluorescent stain results. |
| Recall Action |
Recall |
| Recall Action Instructions |
The following customer actions are recommended:
· Destroy the product in the inventory or return it to Thermo Fisher Scientific.
· If the product has been consumed Thermo Fisher recommend reviewing the results for any anomalies. |
| Contact Information |
1300 736 767 - 1800 636 327 - Thermo Fisher Scientific |