FDA-Device2021-12-08Class II
Total Thyroxine (T4) ELISA; REF EIA-1781
DRG International, Inc.
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.
Sold states
Domestic: NY; International: TZ, VN, BD, CO, TT, YE, BO, DE, SV, GE, PY, TG, RU/UA, NI, DO, NG, EG & CM
Affected count
314 total (270 US)
Manufactured in
841 Mountain Ave, Springfield, NJ, United States
Products
Total Thyroxine (T4) ELISA; REF EIA-1781
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0310-2022Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief