FDAFDA · Alimentos y medicamentos·N.º oficial Z-2713-2026
GSP Neonatal GALT Kit. Product Codes: 3303-001U, 3303-0010. in vitro diagnostic. Used in FLUORESCENT PROC. (QUAL), GALACTOSE-1-PHOSPHATE URIDYL TRANSFERASE.
Publicado el 15 de julio de 2026 · Inicio del retiro: 18 de mayo de 2026
Estado reportado al momento de publicación: Ongoing — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
Reduction in the on-board stability of the GSP GALT assay. This may increase the likelihood of run-QC failures and consequently delay the reporting of patient results.
Qué hacer
Voluntary: Firm initiated · E-Mail
Detalles del retiro
- Fabricante
- WALLAC OY
- Distribuidor
- Worldwide - US Nationwide distribution in the states and territories of AL, AR, AZ, CO, FL, GA, IL, IN, KY, LA, MA, MD, MN, MO, NJ, OR, PR, SC, TN, TX, VA, WV and the countries of Austria, Belgium, Egypt, France, Germany, Hong Kong, Iraq, Italy, Netherlands, Oman, Philippines, Saudi Arabia, Singapore, Spain, Thailand, United Arab Emirates, Vietnam.
- Lote
- 1. Product Code: 3303-001U. UDI-DI: 06438147321704. UDI-PI (PACKING LOT): (01)06438147321704(17)260531(10)763638 (1076363801); (01)06438147321704(17)260531(10)764085 (1076408501); (01)06438147321704(17)260531(10)765033 (1076503301); (01)06438147321704(17)260731(10)765231 (1076523101); (01)06438147321704(17)260731(10)765316 (1076531601); (01)06438147321704(17)261031(10)766420 (1076642001); (01)06438147321704(17)261031(10)766894 (1076689401); (01)06438147321704(17)261130(10)767873 (1076763801); (01)06438147321704(17)261130(10)768361 (1076836101); (01)06438147321704(17)261130(10)768703 (1076870301); (01)06438147321704(17)270228(10)769355 (1076935501); (01)06438147321704(17)270228(10)769542 (1076954201); (01)06438147321704(17)270228(10)769632 (1076963201); (01)06438147321704(17)270228(10)769671 (1076967101); (01)06438147321704(17)270228(10)769782 (1076978201); (01)06438147321704(17)270228(10)769871 (1076987101); (01)06438147321704(17)270228(10)769975 (1076997501); (01)06438147321704(17)270228(10)770078 (1077007801); (01)06438147321704(17)270228(10)770086 (1077008601); (01)06438147321704(17)270228(10)770351 (1077035101). 2. Product Code: 3303-0010. UDI-DI: 06438147311347. UDI-PI (PACKING LOT): (01)06438147311347(17)260531(10)763396 (1076339601); (01)06438147311347(17)260531(10)763396 (1076339602); (01)06438147311347(17)260531(10)764209 (1076420901); (01)06438147311347(17)260531(10)764209 (1076420902); (01)06438147311347(17)260731(10)765317 (1076531702); (01)06438147311347(17)260731(10)7653177 (1076531703); (01)06438147311347(17)261031(10)766378 (1076637801); (01)06438147311347(17)261031(10)766943 (1076694301); (01)06438147311347(17)261031(10)767323 (1076732301); (01)06438147311347(17)261130(10)767955 (1076795501); (01)06438147311347(17)261031(10)767956 (1076795601); (01)06438147311347(17)261130(10)769214 (1076921401); (01)06438147311347(17)261231(10)769967 (1076996701).
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- Finland
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