Estrone RIA kits
Brand(s)
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
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