Official recall record
Estrone RIA kits (ref 77624)
- 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 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
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.
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