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Hycor Biomedical LLC recalls HYTEC Stop Solution (Allergy), 300ml bottle containing 1N sodium hydroxide solution, Part # 308051, sold separately or a
Recalled November 6, 2019 · FDA recall Z-0224-2020 · Hycor Biomedical
Hazard
Some of the Stop Solution bottles, a caustic solution, have been reported to leak. · FDA Class II
Units
185 individual bottles (170 US and 15 OUS) and 1,298/1-bottle kits (OUS)
Sold at
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 and to the following foreign countries: Austria, Denmark, France, Germany, Greece, Italy, Kuwait, Netherlands, Russia, Spain, and United Kingdom.
Description
Some of the Stop Solution bottles, a caustic solution, have been reported to leak.
Product
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.
Manufacturer(s)
Hycor Biomedical LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →