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Access system - total t4 assay

Official notice

15 Feb 2024

Last checked

15 Feb 2024

Medium riskHealth Canada

An official Health Canada notice concerns Access system - total t4 assay. Beckman Coulter has determined that the affected Access Total T4 reagent lots demonstrate an assay imprecision that is higher than expected. An unusual amount of precipitate may be observed in the Access Total T4 reagent packs. Recall start date: February 5, 2024 Published 2024-02-15.

What to do now

Contact the manufacturer if you require additional information.

Recall number

75075

Official notice

2024-02-15

The hazard

Beckman Coulter has determined that the affected Access Total T4 reagent lots demonstrate an assay imprecision that is higher than expected. An unusual amount of precipitate may be observed in the Access Total T4 reagent packs. Recall start date: February 5, 2024

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

75075

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Affected products

Product 1

Affected products - Access System - Total T4 Assay, Lot or serial number - 338555 338734 338958 338556, Model or catalogue number - 33800

Risk / hazard

Beckman Coulter has determined that the affected Access Total T4 reagent lots demonstrate an assay imprecision that is higher than expected. An unusual amount of precipitate may be observed in the Access Total T4 reagent packs. Recall start date: February 5, 2024

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, Access System - Total T4 Assay.

Source & status

Source

Health Canada

Tier

official

Category

HOME

Classification

Type II

App estimate

medium

Recall details

Recall number

75075

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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