FDA recall Z-2087-2026

Product

One Step K in vitro diagnostic test REF: 81A4

Reason for recall

The devices were distributed without required FDA premarket clearance or approval.

Distribution

Worldwide - US Nationwide distribution in the states of FL, PA and the country of England.

Key facts

Status

Ongoing

Initiation date

2026-04-02

Report date

2026-05-13

Voluntary/Mandated

Voluntary: Firm initiated

Location

Gimhae, Korea (the Republic of)

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2087-2026