Hycor Biomedical LLC recalls HYTEC Stop Solution (Allergy), 300ml bottle containing 1N sodium hydroxide solution, Part # 308051, sold separately or…

Recall date

July 25, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0224-2020

FDA classification

Class II

Brand / firm

Hycor Biomedical LLC

Sold / distributed

Stop Solution bottles were distributed to AL, CA, FL, IL, KS, LA, MS, NJ, NY, SC, TX, WA, and to the U.S. Virgin Islands. Foreign distribution of the bottles was made to Germany. There was no government/military distribution. Assay kits containing the Stop Solution bottles were distributed to FL an…

Why it was recalled

Some of the Stop Solution bottles, a caustic solution, have been reported to leak.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

HYTEC Stop Solution (Allergy), 300ml bottle containing 1N sodium hydroxide solution, Part # 308051, sold separately or as a component contained in the following kits: (1) HYTEC Specific/Total IgE EIA kit, Part# 74155; and (2) HYTEC Specific IgG EIA Kit, Part# 74114.