FDA Medical Device Recalls (openFDA)
Immunotech A.S.: Estrone RIA, REF: DSL8700
- Recall number
- Z-1369-2026
- Recalling firm
- Immunotech A.S.
- Product
- Estrone RIA, REF: DSL8700
- Status
- Open, Classified
- Initiated
- 2025-12-15
- Posted
- 2026-02-13
- Terminated
- not on file
- Reason
- The affected Estrone RIA kit lots may rarely give falsely high patient results which might cause Temporary injury of Remote probability. Only in some (very rare) cases may the issue occur.
- Root cause
- Equipment maintenance
- Action
- On 12/15/2025, Beckman Coulter emailed recall notices to customers who were informed of the following: 1) Discard any remaining inventory of affected lots per your laboratory protocols and ask for replacement. 2) Firm recommends sharing the content of this letter with your laboratory and/or medical director. 3) If you have forwarded any of the affected products to another laboratory, provide them a copy of this letter. 4) Complete and return the response form via email to QACZ@beckman.com Questions can be sent to the firm via email at imunochem@beckman.com
- Quantity
- 160
- Distribution
- Worldwide - US Nationwide distribution in the state of NC and the countries of Germany, Argentina, Netherlands, Hungary, Austria, Belgium, France, Italy.
- Lot, serial or model codes
- UDI: 15099590211615. Lot(Expiration): 251013C(2025-12-30), 251110C(2026-01-27)
- 510(k) numbers
- ["K935013"]
- PMA numbers
- not on file
- Product code
- CGF
- Firm FEI
- 3003385757
- Firm city
- Prague 10
- Firm state
- not on file
- Firm country
- Czech Republic
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28