FDA recall Z-1369-2026

Product

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.

Distribution

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

Key facts

Status

Ongoing

Initiation date

2025-12-15

Report date

2026-02-25

Voluntary/Mandated

Voluntary: Firm initiated

Location

Prague 10, Czech Republic

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1369-2026