Xpert EV Assay
Brand(s)
Summary
Discontinue use of affected product, complete response form and dispose of remaining inventory.
Affected products
Affected products |
Lot or serial number |
Model or catalogue number |
|---|---|---|
Xpert EV Assay |
1000408741/22001 |
GXEV-100N-10 |
Issue
On 27-Jul-2022 a non-conformance investigation was initiated for an issue related to a component of the test. In early August 2022, the correlation was made that this component issue may have resulted in customer complaints of invalid and false negative test results that was being investigated separately. The investigation showed that the beads used in the tests caused low sample processing control/internal control endpoints, which could lead to false negative and invalid test results.
Recall start date: August 25, 2022
Additional information
Details
Cepheid
904 Caribbean Drive, Sunnyvale, California, United States, 94089
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