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 | 250331C | DSL-8700 |
| Estrone RIA | 250106D | DSL-8700 |
| Estrone RIA | 250203D | DSL-8700 |
| Estrone RIA | 250428C | DSL-8700 |
| Estrone RIA | 250303C | DSL-8700 |
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
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-77623
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