HYTEC Stop Solution — Class II medical device recall Z-0224-2020
Ongoing recall by Hycor Biomedical LLC, reported 2019-11-06, distributed in AL, CA, FL, IL, KS, LA, MS, NJ…. Some of the Stop Solution bottles, a caustic solution, have been reported to leak.
| Recall number | Z-0224-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hycor Biomedical LLC, Garden Grove, CA, United States |
| Recall initiated | 2018-07-25 |
| Classified | 2019-10-29 |
| Reported by FDA | 2019-11-06 |
| Distributed | AL, CA, FL, IL, KS, LA, MS, NJ, NY, SC, TX, VI, WA |
| Countries outside the US | AT, DE, DK, ES, FR, GB, GR, IT, KW, NL, RU |
| Reason classes | packaging |
| Lot numbers | 154104-10, 154104-11, 154104-7, 154104-8, 154104-9, 154144, 154803, 155324, 156932-1 |
| Model numbers | 308051, 74114, 74155 |
| Expiration dates | 2018-06-30, 2018-09-30, 2018-12-31, 2020-09-30, 2021-03-31 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0224-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.