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Beckman coulter au2700 5400 immunochemistry system - transferrin assay

Official notice

18 Sept 2023

Last checked

18 Sept 2023

Medium riskHealth Canada

An official Health Canada notice concerns Beckman coulter au2700 5400 immunochemistry system - transferrin assay. It has been determined that transferrin ref OSR6152 lot 2573 does not meet the reagent stability claim stated in the Instructions For Use (IFU). Customers may experience reagent blank shifts, calibration failures, and/or QC failures. Recall start date: September 4, 2023 Published 2023-09-18.

What to do now

Contact the manufacturer if you require additional information.

Recall number

74301

Official notice

2023-09-18

The hazard

It has been determined that transferrin ref OSR6152 lot 2573 does not meet the reagent stability claim stated in the Instructions For Use (IFU). Customers may experience reagent blank shifts, calibration failures, and/or QC failures. Recall start date: September 4, 2023

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.

Lots

2573

Recall Numbers

74301

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Affected products

Product 1

Affected products - Beckman Coulter Au2700 Immunochemistry System - Transferrin Assay, Lot or serial number - 2573, Model or catalog number - OSR6152

Product 2

Affected products - Beckman Coulter Au Immunochemistry System - Transferrin Assay, Lot or serial number - 2573, Model or catalog number - OSR6152

Product 3

Affected products - Beckman Coulter Au5400 Immunochemistry System - Transferrin Assay, Lot or serial number - 2573, Model or catalog number - OSR6152

Risk / hazard

It has been determined that transferrin ref OSR6152 lot 2573 does not meet the reagent stability claim stated in the Instructions For Use (IFU). Customers may experience reagent blank shifts, calibration failures, and/or QC failures. Recall start date: September 4, 2023

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

Brand: Beckman Coulter, Beckman Coulter Au2700 5400 Immunochemistry System - Transferrin Assay.

Source & status

Source

Health Canada

Tier

official

Category

HOME

Classification

Type II

App estimate

medium

Recall details

Recall number

74301

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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