FDA recall Z-2171-2026

Product

ZYMUTEST HIA IgG, in vitro diagnostic ELISA kit, Ref. RK040A

Reason for recall

Kits from lot FD1265 had been packaged on 17 October 2024 and put on the market with an outdated flyer (8 October 2024), containing incorrect values for the positive control.

Distribution

US Nationwide distribution in the states of CA, GA, MN, MO, NC, NM, NY, VA, WA, and WI

Key facts

Status

Ongoing

Initiation date

2026-04-01

Report date

2026-05-20

Voluntary/Mandated

Voluntary: Firm initiated

Location

West Chester, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2171-2026