| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-01410-1 |
| Product Name/Description |
Thermofisher Remel Bactipstaph Latex Kits
Items Numbers: R21143
Lot Numbers: 104809
ARTG number 235680 (Thermo Fisher Scientific Australia & New Zealand - Microbial-isolate identification and testing IVDs) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
13/11/2017 |
| Responsible Entity |
|
| Reason/Issue |
An internal technical investigation by Remel has confirmed that the positive control supplied within these kits may be non-reactive. The latex test reagent provided in the kits performs exactly as expected and according to specifications.
No other batches or pack sizes of this product are affected. |
| Recall Action |
Recall |
| Recall Action Instructions |
Thermofisher is advising users to inspect stock and quarantine any remaining units of the affected batch from use. The requirement for a review of previously generated results is at the discretion of the Laboratory Director.
This action has been closed out on 30/10/2018 |
| Contact Information |
08 8238 9044 - Customer Service Manager |