| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-01257-1 |
| Product Name/Description |
Xpert EV Assay. An in vitro diagnostic medical device (IVD)
Part Number: GXEV-100N-10
Batch Number: 1000045409
Lot Number: 06802
Expiry Date: 04 November 2018
ARTG Number: 221804 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
9/10/2017 |
| Responsible Entity |
|
| Reason/Issue |
Customers have reported a higher than expected number of invalid test results or probe check low (E5007) errors when using the affected product.
Patient results are not reported for invalid tests and the test report is designated as “invalid”. |
| Recall Action |
Recall |
| Recall Action Instructions |
Cepheid is advising users to stop using the affected product. Any remaining product should be discarded. Cepheid will provide replacement product.
This action has been closed out on the 25/09/2018. |
| Contact Information |
1800 107 884 - Cepheid |