Health product recall

Estrone RIA kits

Last updated

Summary

Product
Estrone RIA kits
Issue
Medical devices - Performance
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalog number

Estrone RIA

250203C

DSL-8700

Estrone RIA

250331C

DSL-8700

Estrone RIA

250106D

DSL-8700

Estrone RIA

250203D

DSL-8700

Estrone RIA

250428C

DSL-8700

Estrone RIA

250303C

DSL-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

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Chemistry
Companies

Immunotech S.R.O.

Radiova 1122/1, Praha 10, Czech Republic, 10200

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-77623

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