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Xpert ev assay
Official notice
20 Sept 2022
Last checked
20 Sept 2022
An official Health Canada notice concerns Xpert ev assay. 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 Published 2022-09-20.
What to do now
Discontinue use of affected product, complete response form and dispose of remaining inventory.
Recall number
64561
Official notice
2022-09-20
The hazard
The hazard
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
How to check if you're affected
How to check if you're affected
Compare the product name and identifiers below with the item you own. Follow the official notice if they match.
Recall Numbers
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Turn on recall alertsAffected products
Affected products
Product 1
Risk / hazard
Where it was sold
Where it was sold
The source does not list specific retailers. See the official notice for where affected products were sold.
Location 1
Affected area 1
Company & contacts
Company & contacts
Brand: Cepheid, Xpert Ev Assay.
Source & status
Source & status
Source
Tier
Category
Classification
App estimate
Recall details
Recall details
Recall number
Classification
Source tier
Documents, notices & source
See the official notice and source documents for full details.
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