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 RIA250331CDSL-8700
Estrone RIA250106DDSL-8700
Estrone RIA250203DDSL-8700
Estrone RIA250428CDSL-8700
Estrone RIA250303CDSL-8700

Issue

Beckman Coulter has determined that the affected Estrone RIA kits may be affected by an increased probability of falsely elevated results. Assay results may be falsely increased (sample medians may be falsely increased). Based on investigational data, the increase of sample medians was maximally +37%. Recall start date: June 9, 2025

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