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Health Canada Medical devices

Estrone RIA kits

Issued June 18, 2025
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
Hazard description
Performance
Product
Product name
Estrone RIA kits
Reference
ID
RA-77623