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Ortho optix™ reader
Official notice
19 Apr 2022
Last checked
19 Apr 2022
An official Health Canada notice concerns Ortho optix™ reader. Ortho Clinical Diagnostics received a complaint regarding an incorrectly displayed passing QC status for a test (see example in table below), without the site having processed the multiple QC kits configured for the test. Ortho confirmed that any test processed with multiple QC kits may encounter this issue. If one QC kit out of the multiple QC kits configured for the test has successfully passed, the software will automatically assign a passing QC status to the test even if the other QC kit configured for the test is not run or does not pass. Recall start date: Apr 11, 2022 Published 2022-04-19.
What to do now
Contact the manufacturer if you require additional information.
Recall number
64093
Official notice
2022-04-19
The hazard
The hazard
Ortho Clinical Diagnostics received a complaint regarding an incorrectly displayed passing QC status for a test (see example in table below), without the site having processed the multiple QC kits configured for the test. Ortho confirmed that any test processed with multiple QC kits may encounter this issue. If one QC kit out of the multiple QC kits configured for the test has successfully passed, the software will automatically assign a passing QC status to the test even if the other QC kit configured for the test is not run or does not pass. Recall start date: Apr 11, 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: Ortho-clinical Diagnostics, Ortho Optix™ Reader.
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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