Recall Z-1369-2026 ยท CGF Radioimmunoassay, Estrone
Immunotech A.S.
Estrone RIA, REF: DSL8700
| Date | Feb 13, 2026 (initiated Dec 15, 2025) |
| Status | Open, Classified |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K935013 | DSL ESTRONE (DSL 8700) Diagnostic Systems Laboratories, Inc., Jun 16, 1994 |