FDA recall Z-0310-2022

Product

Total Thyroxine (T4) ELISA; REF EIA-1781

Reason for recall

Firm has identified two lots of product that do not meet product shelf life, resulting in failed Controls. The clinical impact may be a delay in diagnosis and a consumption of patient samples.

Distribution

Domestic: NY; International: TZ, VN, BD, CO, TT, YE, BO, DE, SV, GE, PY, TG, RU/UA, NI, DO, NG, EG & CM

Key facts

Status

Ongoing

Initiation date

2021-10-18

Report date

2021-12-08

Voluntary/Mandated

Voluntary: Firm initiated

Location

Springfield, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0310-2022