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

241209C

DSL-8700

Estrone RIA

250106D

DSL-8700

Estrone RIA

250106C

DSL-8700

Estrone RIA

241111C

DSL-8700

Estrone RIA

241014D

DSL-8700

Estrone RIA

241209D

DSL-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

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-77624

Get notified

Receive emails about new and updated recall and safety alerts.

Subscribe