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Ortho vision analyzers
Official notice
14 Oct 2022
Last checked
14 Oct 2022
An official Health Canada notice concerns Ortho vision analyzers. During normal operation of the ortho vision analyzer, the camera imaging subsystem (CIMS) interfaces with a hardware camera to request and retrieve camera images for column grading and results interpretation. The camera software uses a first-in, first-out queuing system to take and return images to the CIMS software. Under an atypical software anomaly, images used for analysis of a test result did not come from the front and back sides of the same card. Ortho determined that the CIMS processed images out of synchronization (images captured earliest in sequence are placed at the top of the queue to be processed). As a result, image processing software utilized on the ortho vision analyzer may use mismatched front of card and back of card images for column grading and result interpretation. Recall start date: September 22, 2022 Published 2022-10-14.
What to do now
Contact the manufacturer if you require additional information.
Recall number
72021
Official notice
2022-10-14
The hazard
The hazard
During normal operation of the ortho vision analyzer, the camera imaging subsystem (CIMS) interfaces with a hardware camera to request and retrieve camera images for column grading and results interpretation. The camera software uses a first-in, first-out queuing system to take and return images to the CIMS software. Under an atypical software anomaly, images used for analysis of a test result did not come from the front and back sides of the same card. Ortho determined that the CIMS processed images out of synchronization (images captured earliest in sequence are placed at the top of the queue to be processed). As a result, image processing software utilized on the ortho vision analyzer may use mismatched front of card and back of card images for column grading and result interpretation. Recall start date: September 22, 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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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 Vision Analyzers.
Source & status
Source & status
Source
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Category
Classification
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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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