| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00375-1 |
| Product Name/Description |
Xpert CT/NG Assay. An in vitro diagnostic medical device (IVD)
Catalogue Number: GXCT/NG-CE-10
Lot Number: 100044234
Cartridge Lot Number: 11715
Expiration Date: 29 July 2018
ARTG Number: 207540 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
21/03/2017 |
| Responsible Entity |
|
| Reason/Issue |
Reports have been received that some customers have experienced a higher number of invalid results than would typically be expected when using the Xpert CT/NG assay and its intended use specimen types. This could lead to the need to retest and consequently, a delay in test results and subsequent treatment. |
| Recall Action |
Recall |
| Recall Action Instructions |
Cepheid is advising users to discontinue use and discard affected stock in their inventory. Users are further advised to acknowledge receipt of the recall letter and return it to Cepheid customer service in order to receive replacement stock.
This action has been closed-out on 22/03/2018. |
| Contact Information |
1800 107 884 - Cepheid |