Official recall record
Estrone RIA kits (ref 77623)
- Issuing authority
- Health Canada — Medical Devices
- Published
- 2025-06-18
- Country of alert
- Canada
- Alert level
- Type II
- Alert type
- recall
What the authority reported
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
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
Health Canada — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.
Record last checked against the registry on 2026-05-31.
ProductGuru Recalls republishes official safety information with attribution. We are not
the issuing authority and this page is not advice. If this product is a medical device or
medication, speak to a doctor or pharmacist. Found an error?
Report it — corrections are published.