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Ortho vision analyzers
Official notice
4 Jan 2023
Last checked
4 Jan 2023
An official Health Canada notice concerns Ortho vision analyzers. Ortho's investigation discovered that the self-service customer procedures guide, both onboard and offboard, contains 2 errors related to the probe installation/removal process (chapter 4). 1. The self-service customer procedure guide contains a note indicating the probe can be replaced without using the software maintenance task. If it is performed this way, the instructions do not instruct the operator to condition the probe (daily maintenance) after replacement, which is a required post requisite activity. 2. The self-service customer procedure guide contains a note indicating the software will initiate the pump test, after probe replacement is complete. This is incorrect, since upon completion of the probe replacement maintenance task, the software marks the pipetting volume test as pending rather than the pump test. Note: if the user follows the software's on-screen instructions, daily maintenance is automatically performed during the probe replacement task and the operator is notified of the pending pipetting volume test, which if completed, mitigates this issue. To date, no customer complaints have been recorded regarding this issue. Recall start date: December 21, 2022 Published 2023-01-04.
What to do now
Contact the manufacturer if you require additional information.
Recall number
72514
Official notice
2023-01-04
The hazard
The hazard
Ortho's investigation discovered that the self-service customer procedures guide, both onboard and offboard, contains 2 errors related to the probe installation/removal process (chapter 4). 1. The self-service customer procedure guide contains a note indicating the probe can be replaced without using the software maintenance task. If it is performed this way, the instructions do not instruct the operator to condition the probe (daily maintenance) after replacement, which is a required post requisite activity. 2. The self-service customer procedure guide contains a note indicating the software will initiate the pump test, after probe replacement is complete. This is incorrect, since upon completion of the probe replacement maintenance task, the software marks the pipetting volume test as pending rather than the pump test. Note: if the user follows the software's on-screen instructions, daily maintenance is automatically performed during the probe replacement task and the operator is notified of the pending pipetting volume test, which if completed, mitigates this issue. To date, no customer complaints have been recorded regarding this issue. Recall start date: December 21, 2022
How to check if you're affected
How to check if you're affected
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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
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Recall details
Recall details
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Documents, notices & source
See the official notice and source documents for full details.
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