| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01487-1 |
| Product Name/Description |
Xpert MRSA/SA Blood Culture Assay. An in vitro diagnostic medical device (IVD).
Catalogue Number: GXMRSA/SA-BC-CE-10
Lot Number: 1000025828 (cartridge lot 12803)
Expiry date: 2 April 2017
ARTG Number: 242177 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
21/11/2016 |
| Responsible Entity |
|
| Reason/Issue |
Cepheid has received reports that some customers have experienced a higher number of invalid results than would typically be expected when using this test and its intended use specimen types. As in all Xpert assays, when the test is determined to be invalid due to a failure of a cartridge or instrument quality check, no patient results are reported and the report designation is “invalid.” |
| Recall Action |
Recall |
| Recall Action Instructions |
Cepheid is advising customers to stop using the affected lot and dispose of any remaining product of this lot in their inventory. Cepheid will provide replacement product. This action has been closed-out on 18/05/2017. |
| Contact Information |
1800 107 884 - Cepheid |