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Ortho optix™ reader
Official notice
25 Nov 2022
Last checked
25 Nov 2022
An official Health Canada notice concerns Ortho optix™ reader. 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 Published 2022-11-25.
What to do now
Contact the manufacturer if you require additional information.
Recall number
72209
Official notice
2022-11-25
The hazard
The hazard
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
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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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: Beckman Coulter Ireland, 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.
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