Health product recall

Ortho Vision Analyzer

Last updated

Summary

Product
Ortho Vision Analyzer
Issue
Medical devices - Performance
What to do

Contact the manufacturer if you require additional information. 

Affected products

Affected products

Lot or serial number

Model or catalog number

Ortho Vision Analyzer

More than 10 numbers, contact manufacturer.

6904577

Ortho Vision Max Analyzer

Not applicable.

6153434

Ortho Vision Max Analyzer

More than 10 numbers, contact manufacturer.

6904576

Issue

The loading station door unlocks for 20 seconds upon request to load samples or diluents. If the door is not opened within this period, it relocks without triggering a re-inventory since no user access occurred. If the door is opened immediately after the allotted 20-second countdown ends but within the door's auto-relock timeframe, the user will be allowed to load samples, however, re-inventory will not be triggered as the software does not detect that the loading station door was opened. There are no error codes generated for this issue. An inventory event will take place the next time you properly access the loading station.

Recall Start Date: April 25, 2025

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Haematology
Companies

Ortho-Clinical Diagnostics Inc.

1001 Us Hwy 202, Raritan, New Jersey, United States, 08869

Published by
Health Canada
Audience
General public
Healthcare
Industry
Recall class
Type II
Identification number
RA-77425

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