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Ortho optix™ reader

Official notice

25 Nov 2022

Last checked

25 Nov 2022

Medium riskHealth Canada

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

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

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Recall Numbers

72209

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Affected products

Product 1

Affected products - Ortho Optix™ Reader, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - 6842222

Risk / 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

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Beckman Coulter Ireland, Ortho Optix™ Reader.

Source & status

Source

Health Canada

Tier

official

Category

HOME

Classification

Type II

App estimate

medium

Recall details

Recall number

72209

Classification

Type II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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