Beckman Coulter Estrone RIA Kit Recall: False High Estrone Results
Beckman Coulter recalls Estrone RIA kits with specific lots due to false high estrone results from BSA issues. Affected kits may give inaccurate test results.
Lower-risk recall
A specific lot of bovine serum albumin (BSA) used for manufacturing of coated tubes (CT) that are included in the Estrone RIA kit lots caused different affinity of manufactured coated tubes to patient samples, causing falsely increased assay results for the impacted Estrone RIA kits.
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What happened, in plain English
Beckman Coulter is recalling specific lots of Estrone RIA kits that may give falsely high estrone test results. This could lead to incorrect medical decisions if used without knowing the problem. Read more at govinfonow.com/recall/52045-beckman-coulter-estrone-ria-kit-recall-false-high-estrone-results.
Source Summary by GovInfoNow · govinfonow.com/recall/52045-beckman-coulter-estrone-ria-kit-recall-false-high-estrone-results · Updated August 17, 2026 · FDA enforcement record: FDA #Z-2152-2025
Cite this page
“Beckman Coulter Estrone RIA Kit Recall: False High Estrone Results.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/52045-beckman-coulter-estrone-ria-kit-recall-false-high-estrone-results. Based on FDA recall #Z-2152-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2152-2025%22&limit=1).
Why it’s dangerous
The kits use a specific lot of bovine serum albumin that causes coated tubes to react differently with patient samples. This leads to falsely increased estrone test results, which could cause incorrect medical decisions.
Who’s affected
People using Estrone RIA kits with the listed lots for hormone testing may be affected. Those with medical conditions requiring accurate estrone levels are at higher risk.
How to tell if you have this one
Check the kit's UDI: 15099590211615 and lot numbers: 250106D, 250203C, 250203D, 250303C, 250331C, 250428C, 250526C. These lots were sold with the Estrone RIA kit (REF: DSL8700).
- Brand
Beckman Coulter- Category
Medical device
What to do — step by step
Check Kit Lot Numbers
Look for the lot numbers listed: 250106D, 250203C, 250203D, 250303C, 250331C, 250428C, 250526C on the kit's UDI.
Where it went and when
Where it was distributed
Distributed in North Carolina, and outside the U.S.
FDA distribution: “US: North Carolina OUS: Argentina, Austria, Belgium, Canada, France, Germany, Greece, Hungary, Italy, Netherlands” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: North Carolina.
Recall timeline
FDA published this recall 48 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Questions people ask
Is this a safety hazard?
This is a potential for inaccurate test results, not a direct safety hazard. The risk is low as it affects test accuracy, not physical harm.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-2152-2025 (June 12, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2152-2025 to see it in context.
- Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.