| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-01157-1 |
| Product Name/Description |
TM0268 GC Sugar Set. An in vitro diagnostic medical device (IVD)
Lot Number: 1458901
ARTG Number: 214128 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
6/09/2017 |
| Responsible Entity |
|
| Reason/Issue |
Thermo Fisher received an internal technical investigation confirming that a specific lot of TM0268 GC Sugar Set may provide atypical performance when used with some strains of Neisseria species. False negative results may be seen with the glucose reaction with some strains. Continued use of this lot may result in incorrect results reporting or a delay to results reporting due to additional testing requirements. |
| Recall Action |
Recall |
| Recall Action Instructions |
1. Inspect and remove from further use all units from the affected batch number, then complete the supplied Facsimile Reply Form and return for a credit note to be issued.
This action has been closed out on the 12/09/2018 |
| Contact Information |
08 8238 9044 - Thermo Fisher Scientific |