Recall Monitor
Health Products

Estrone RIA kits

· Published by Health Canada · Official notice

Details

Alert type: Health product recall
Category: Health products - Medical devices - Chemistry
Product: Estrone RIA kits
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare
Recall class: Type II
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Products

Affected productsLot or serial numberModel or catalog number
Estrone RIA250203CDSL-8700
Estrone RIA241209CDSL-8700
Estrone RIA250106DDSL-8700
Estrone RIA250106CDSL-8700
Estrone RIA241111CDSL-8700
Estrone RIA241014DDSL-8700
Estrone RIA241209DDSL-8700

Issue

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

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