United StatesReQuest Measles IgG Rubeola IgG Enzyme Linked Immunoabsorbant Assay (catalog number 01-190), lots L07024 and E03025 (Lot Code DI# 00850487007357), distributed in the United States (including Utah and Washington), is affected. The product was recalled because the measles IgG in vitro diagnostic was distributed without a premarket approval or clearance. Quest International, Inc. of Doral, FL is the recalling firm.
What's being recalled
Brand Name: ReQuest Measles IgG Product Name: Rubeola IgG Enzyme Linked Immunoabsorbant Assay Model/Catalog Number: 01-190 Software Version: N/A Product Description: Measles IgG tests, performed using ELISA (Enzyme-Linked Immunosorbent Assay) method, used to detect the presence of IgG antibodies against measles virus in a patient's serum or plasma Component: not a component
Recalling firm: Quest International, Inc., Doral, FL, United States.
How to identify it
Lot Code: DI# 00850487007357 Lots affected: L07024 and E03025
The hazard
Due to distributing the measles IgG IVD without a premarket approved/cleared.
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
All products were distributed in the United States. (Utah, Washington).
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)