| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00819-1 |
| Product Name/Description |
Xpert Xpress CoV-2/Flu/RSV plus. An in vitro diagnostic medical device (IVD)
Part number: XP3COV2/FLU/RSV-10
Batch numbers: 1001420157, 1001421769, 1001423028, 1001423031
Lot numbers: 19108, 19208, 19214, 19219
Expiry dates: 09-Mar-25, 23-Mar-25, 30-Mar-25, 30-Mar-25
ARTG 231513
(Cepheid Holdings Pty Ltd - Multiple-viruses IVDs) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
25/09/2024 |
| Responsible Entity |
|
| Reason/Issue |
There have been reports that some Cepheid customers have encountered a higher number of Error E5007 "Probe Check Too Low errors" than would typically be expected when performing these tests as described in the product list and their intended use specimen types. An Error E5007 yields a nondeterminate result (Error). |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
If a user experiences an E5007 error when using a cartridge from the product list, they should repeat testing on another cartridge.
If another Error E5007 error occurs, or if the user has been experiencing intermittent E5007 errors on tests from these lots, Cepheid will replace any remaining tests in customers' inventory from affected lots. |
| Contact Information |
1800 107 844 - Ricky Widjaja |