# FDA recall Z-0224-2020

> **Hycor Biomedical LLC** · Class II · device recall initiated 2018-07-25.

## 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

- **Recall number:** Z-0224-2020
- **Recalling firm:** Hycor Biomedical LLC
- **Classification:** Class II
- **Product type:** device
- **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

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

## Citation

> AI Analytics. FDA recall Z-0224-2020. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-0224-2020. Source: US FDA. Licensed CC0.

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