Class II — Hycor Biomedical LLC
| Recalling firm | Hycor Biomedical |
|---|---|
| Registered facility | HYCOR BIOMEDICAL (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | 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. |
| Quantity | 185 individual bottles (170 US and 15 OUS) and 1,298/1-bottle kits (OUS) |
| 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, Kuwai… |
| Initiated | 2018-07-25 |
| Classified | 2019-10-29 |
| Recall number | Z-0224-2020 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Hycor Biomedical LLC (Z-0224-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/83853/
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