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.
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.
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.
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.
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.
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).
Look for the lot numbers listed: 250106D, 250203C, 250203D, 250303C, 250331C, 250428C, 250526C on the kit's UDI.
The specific lot of bovine serum albumin used in these kits causes coated tubes to react differently with patient samples, leading to falsely increased estrone test results.
Check the lot numbers on your kit. If it matches the listed lots, contact Beckman Coulter for instructions.
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.
We’ve drafted a message you can send Beckman Coulter to request your refund or repair — edit it as you like.
Subject: Recall Z-2152-2025 — Beckman Coulter Beckman Coulter Hello, I own a Beckman Coulter that is covered by recall Z-2152-2025 from Beckman Coulter. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
