FDA Device recall Z-0224-2020
HYTEC Stop Solution (Allergy), 300ml bottle containing 1N sodium hydroxide solution, Part # 308051, sold separately or as a component conta…
- FDA Device
- Class II
- ongoing
- Published 2019-11-06
On 2019-11-06 the FDA classified a Class II recall of HYTEC Stop Solution (Allergy), 300ml bottle containing 1N sodium hydroxide solution, Part # 308051, sold separately or as a component conta… by Hycor Biomedical, citing some of the Stop Solution bottles, a caustic solution, have been reported to leak.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0224-2020 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2018-07-25 |
| Published | 2019-11-06 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Hycor Biomedical |
| Distribution | AL, CA, FL, IL, KS, LA, MS, NJ, NY, SC, TX, WA |
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
Some of the Stop Solution bottles, a caustic solution, have been reported to leak.
Identifiers
| code_info | Stop Solution bottles, REF 308051 - Lot numbers 154803, exp. 31-MAR-2021; and 154144, exp. 30-SEP-2020; HYTEC Specif…Stop Solution bottles, REF 308051 - Lot numbers 154803, exp. 31-MAR-2021; and 154144, exp. 30-SEP-2020; HYTEC Specific & Total IgE Kit, REF 74155, Lot numbers 154104-11, exp. 30-SEP-2018; and 156932-1, exp. 30-JUN-2018 - all contain Stop Solution lot 154803; HYTEC Specific & Total IgE Kit, REF 74155, Lot numbers 154104-10, exp. 30-SEP-2018; 154104-7, exp. 30-SEP-2018; 154104-8, exp. 30-SEP-2018; and 154104-9, exp. 30 SEP-2018 - all contain Stop Solution lot 154144; and HYTEC Specific IgG EIA ref 74114, Lot number 155324, exp. 31-DEC-2018 - contains Stop Solution lot 154144. |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0224-2020%22
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