Beckman Coulter Inc. 2025-07-30 Health serious FDA
Health · FDA · Recall #FDA-Z-2152-2025
Estrone RIA, REF: DSL8700. Estrone RIA is an IVD used for the quantitative measurement… Recall
Issued July 30, 2025 · Beckman Coulter Inc.
In July 2025, Beckman Coulter Inc. recalled the Estrone RIA, REF: DSL8700. Estrone RIA is an IVD used for the quantitative measurement…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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.
What you should do
- 1 Stop using Estrone RIA, REF: DSL8700. Estrone RIA is an IVD used for the quantitative measurement… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Beckman Coulter Inc. to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Beckman Coulter Inc.
- Category
- Health
- Recall date
- July 30, 2025
- Units affected
- Not reported
- Sold at
- US: North Carolina OUS: Argentina, Austria, Belgium, Canada, France, Germany, Greece, Hungary, Italy, Netherlands
- Recall number
- FDA-Z-2152-2025
- Made in
- United States
- Issuing agency
- FDA
In context
- Beckman Coulter Inc. has 4 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 691st Health recall we've logged in 2025.