FDA recall Z-0224-2020

Hycor Biomedical LLC · Class II · device

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.

Reason for recall

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

Distribution

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.

Key facts

Status
Ongoing
Initiation date
2018-07-25
Report date
2019-11-06
Voluntary/Mandated
Voluntary: Firm initiated
Location
Garden Grove, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0224-2020