United StatesGet Tested International Ab is recalling Alcohol (ALC) Test Saliva (SKU A-ALC-S) along with 87 other at‑home and professional test products (multiple SKUs and EANs, all lots) sold nationwide in the United States. The products are being recalled because they were distributed without required FDA premarket approval or clearance.
What's being recalled
Alcohol (ALC) Test Saliva
Blood Type Test
Candida Test
Chlamydia Test
D-Dimer Test
Diabetes HbA1c Test
Illegally Marketed
Drug Test Small (4 substances)
Epstein-Barr Virus (EBV VCA & EBNA IgG) Test
Fecal Occult Blood Test
Female Fertility Test
Gonorrhea test
H pylori (Peptic ulcer) Test
Herpes (HSV-1 & HSV-2) Test
HPV Antigen Test
And 73 more products.
Recalling firm: Get Tested International Ab, Vastervik, Sweden.
How to identify it
EAN: 7340221708884; SKU: A-ALC-S; UDI-DI: None; Lot/Serial Number: All Lots; EAN: 7340221708136; SKU: A-BG; UDI-DI: None; Lot/Serial Number: All Lots; EAN: 7340221700888; SKU: B-CAN; UDI-DI: None; Lot/Serial Number: All Lots; EAN: 7340221701663; SKU: A-ICH; UDI-DI: None; Lot/Serial Number: All Lots; EAN: 7340221700475; SKU: A-CDM; UDI-DI: None; Lot/Serial Number: All Lots; EAN: 7340221707191; SKU: A-HbA1c; UDI-DI: None; Lot/Serial Number: All Lots; EAN: 7340221701083; SKU: A-DR12; UDI-DI: None; Lot/Serial Number: All Lots; EAN: 7340221701045; SKU: A-DR4; UDI-DI: None; Lot/Serial Number: All Lots; EAN: 7340221708211; SKU: A-EBV; UDI-DI: None; Lot/Serial Number: All Lots; EAN: 7340221700642; SKU: A-FOB; UDI-DI: None; Lot/Serial Number: All Lots; EAN: 7340221707139; SKU: A-AMH; UDI-DI: None; Lot/Serial Number: All Lots; EAN: 7340221701533; SKU: A-IGO; UDI-DI: None; Lot/Serial Number: All Lots; EAN: 7340221700604; SKU: A-PYL; UDI-DI: None; Lot/Serial Number: All Lots; EAN: 7340221710047; SKU: A-HSV; UDI-DI: None; Lot/Serial Number: All Lots; EAN: 7340221708259; SKU: A-HPV; UDI-DI: None; Lot/Serial Number: All Lots; EAN: 7340221700840; SKU: A-FER; UDI-DI: None; Lot/Serial Number: All Lots; EAN: 7340221700468; SKU: A-ILY; UDI-DI: None; Lot/Serial Number: All Lots; EAN: 7340221700437; SKU: A-FSH; UDI-DI: None; Lot/Serial Number: All Lots; EAN: 7340221708976; SKU: A-MPVAR; UDI-DI: None; Lot/Serial Number: All Lots; EAN: 7340221710030; SKU: A-MYC; UDI-DI: None; Lot/Serial Number: All Lots; EAN: 7340221700451; SKU: A-LH; UDI-DI: None; Lot/Serial Number: All Lots; EAN: 7340221707153; SKU: A-PARA; UDI-DI: None; Lot/Serial Number: All Lots; EAN: 7340221700697; SKU: A-HCG; UDI-DI: None; Lot/Serial Number: All Lots; EAN: 7340221700444; SKU: A-SPE; UDI-DI: None; Lot/Serial Number: All Lots; EAN: 7340221701656; SKU: A-ISY; UDI-DI: None; Lot/Serial Number: All Lots; EAN: 7340221700567; SKU: A-TSH; UDI-DI: None; Lot/Serial Number: All Lots; EAN: 7340221707245; SKU: A-ITV; UDI-DI…
The hazard
Distribution without premarket approval/clearance.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
US Nationwide distribution.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)