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Estrone ria kits

Official notice

18 Jun 2025

Last checked

18 Jun 2025

Medium riskHealth Canada

An official Health Canada notice concerns Estrone ria kits. Beckman Coulter has determined that the affected Estrone RIA kit lots might be affected by an isolated coated tubes inhomogeneity issue causing falsely elevated results or falsely decreased results. The lots at issue have expired but Beckman Coulter is alerting customers in case there is a determination that a retrospective review of results is necessary. Recall start date: June 9, 2025 Published 2025-06-18.

What to do now

Contact the manufacturer if you require additional information.

Recall number

77624

Official notice

2025-06-18

The hazard

Beckman Coulter has determined that the affected Estrone RIA kit lots might be affected by an isolated coated tubes inhomogeneity issue causing falsely elevated results or falsely decreased results. The lots at issue have expired but Beckman Coulter is alerting customers in case there is a determination that a retrospective review of results is necessary. Recall start date: June 9, 2025

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

77624

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Affected products

Product 1

Affected products - Estrone RIA, Lot or serial number - 250203C, Model or catalog number - DSL-8700

Product 2

Affected products - Estrone RIA, Lot or serial number - 241209C, Model or catalog number - DSL-8700

Product 3

Affected products - Estrone RIA, Lot or serial number - 250106D, Model or catalog number - DSL-8700

Product 4

Affected products - Estrone RIA, Lot or serial number - 250106C, Model or catalog number - DSL-8700

Product 5

Affected products - Estrone RIA, Lot or serial number - 241111C, Model or catalog number - DSL-8700

Product 6

Affected products - Estrone RIA, Lot or serial number - 241014D, Model or catalog number - DSL-8700

Product 7

Affected products - Estrone RIA, Lot or serial number - 241209D, Model or catalog number - DSL-8700

Risk / hazard

Beckman Coulter has determined that the affected Estrone RIA kit lots might be affected by an isolated coated tubes inhomogeneity issue causing falsely elevated results or falsely decreased results. The lots at issue have expired but Beckman Coulter is alerting customers in case there is a determination that a retrospective review of results is necessary. Recall start date: June 9, 2025

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: Immunotech S.r.o, Estrone Ria Kits.

Source & status

Source

Health Canada

Tier

official

Category

HOME

Classification

Type II

App estimate

medium

Recall details

Recall number

77624

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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