No image published for this recall
Ortho optix™ reader
Official notice
22 Aug 2022
Last checked
22 Aug 2022
An official Health Canada notice concerns Ortho optix™ reader. On the Ortho Optix Reader, when reviewing the results, the user can edit a grade and/or analysis of the results. • When performing this action, the user may also choose to "cancel" the edit. •Wwhen cancelling the edit, the user is informed that the "changes have not been saved" via a user interface prompt, which the user must "acknowledge/accept". • After the user "accepts", the result displayed on the user interface reverts as expected back to the original result and awaits result approval. • However, when the user completes "result approval", the result that is unexpectedly stored in the database and reported out of the system (such as to a connected lis) is the "edited result" that was previously cancelled. When this anomaly occurs, there is potential for an erroneous result to be stored in the database and reported out of the system. Recall start date: August 12, 2022 Published 2022-08-22.
What to do now
Contact the manufacturer if you require additional information.
Recall number
64491
Official notice
2022-08-22
The hazard
The hazard
On the Ortho Optix Reader, when reviewing the results, the user can edit a grade and/or analysis of the results. • When performing this action, the user may also choose to "cancel" the edit. •Wwhen cancelling the edit, the user is informed that the "changes have not been saved" via a user interface prompt, which the user must "acknowledge/accept". • After the user "accepts", the result displayed on the user interface reverts as expected back to the original result and awaits result approval. • However, when the user completes "result approval", the result that is unexpectedly stored in the database and reported out of the system (such as to a connected lis) is the "edited result" that was previously cancelled. When this anomaly occurs, there is potential for an erroneous result to be stored in the database and reported out of the system. Recall start date: August 12, 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
Checked manually this time?
The app alerts you when a new official recall is published — no searching, no checking back.
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.
View full official noticeWeekly recall digest
Get next week's recalls before you need them.
One email every Monday — official-source recalls for your country, and nothing else. Unsubscribe from any email.
The digest is the slow lane — one email a week. For instant, severity-gated alerts the moment a notice is published, get the app.
This recall was published 22 Aug 2022. The next one won't wait for you to search.
RecallScope watches official sources for the brands and VINs you follow, and alerts you the moment a new notice is published.
