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DRG International, Inc. recalls Total Thyroxine (T4) ELISA; REF EIA-1781
Recalled December 8, 2021 · FDA recall Z-0310-2022 · DRG International
Hazard
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. · FDA Class II
Units
314 total (270 US)
Sold at
Domestic: NY; International: TZ, VN, BD, CO, TT, YE, BO, DE, SV, GE, PY, TG, RU/UA, NI, DO, NG, EG & CM
Description
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.
Product
Total Thyroxine (T4) ELISA; REF EIA-1781
Manufacturer(s)
DRG International, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →