Health product recall

Ortho Optix™ Reader

Last updated

Summary

Product
Ortho Optix™ Reader
Issue
Medical devices - Performance issue
What to do

Contact the manufacturer if you require additional information.

Affected products

Affected products

Lot or serial number

Model or catalog number

Ortho Optix™ Reader

More than 10 numbers, contact manufacturer.

6842222

Issue

Ortho confirmed when multiple orders are processed for the same patient on the Ortho Optix™ Reader, the software may not be able to identify the orders are for the same patient and may not perform the discrepant result checks in 4 different scenarios listed below.

Scenario 1:
1. an lis order record containing 'attending physician' data (field p14) is imported.
2. a manual order is created for the same patient without any modifications to patient demographics (using patient search).
3. the orders are processed to completion. in this scenario, the 'attending physician' information is not included in the manual order. the software detects the manual order as a different version of the patient than the lis order (containing the 'attending physician' data) and the discrepant result check is not performed.

Scenario 2:
1. a manual order is created.
2. an lis order is created for the same patient containing 'attending physician' data.
3. the orders are processed to completion. if these steps occur, the software detects the lis order (containing the 'attending physician' data) as a different 
version of the patient than the manual order and the discrepant result check is not performed.

Scenario 3:
1. an order is created by either importing an lis order or creating a manual order for a new patient.
2. a manual order is created for the same patient (using patient search) and the patient demographic is modified (for example first name, last name, birthdate, or national id).
3. the orders are processed to completion.

 

Recall start date: November 10, 2022

Additional information

Details
Original published date: 2022-11-25
Alert / recall type
Health product recall
Category
Health product - Medical device - 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-72209