Class IIReported 2026-02-25

Estrone RIA, REF: DSL8700

Reason for Recall

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.

Recall Number

Z-1369-2026

Classification

Class II

Status

Ongoing

Category

device

Initiated

2025-12-15

Reported

2026-02-25

Distribution

Worldwide - US Nationwide distribution in the state of NC and the countries of Germany, Argentina, Netherlands, Hungary, Austria, Belgium, France, Italy.

Code Info

UDI: 15099590211615. Lot(Expiration): 251013C(2025-12-30), 251110C(2026-01-27)

Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.