FDA-Device2019-11-06Class II
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.
Hycor Biomedical LLC
Hazard
Some of the Stop Solution bottles, a caustic solution, have been reported to leak.
Sold states
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.
Affected count
185 individual bottles (170 US and 15 OUS) and 1,298/1-bottle kits (OUS)
Manufactured in
7272 Chapman Ave, Garden Grove, CA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0224-2020Don't want to check this manually?
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