Z-0224-2020Class II

HYTEC Stop Solution (Allergy), 300ml bottle containing 1N sodium hydroxide solution, Part # 308051, sold...

Name: Z-0224-2020 HYTEC Stop Solution (Allergy), 300ml bottle containing 1N sodium hydroxide solution, Part # 308051, sold...
Creator: Hycor Biomedical LLC
Published: 2018-07-25
License: https://open.fda.gov/license/

Hycor Biomedical / initiated 2018-07-25 / Open, Classified / root cause: manufacturing process

FDA source

Hycor Biomedical LLC began a recall of HYTEC Stop Solution (Allergy), 300ml bottle containing 1N sodium hydroxide solution, Part # 308051, sold separately or as a component contained in the... on 2018-07-25. FDA classified it as Class II and gives the reason as "Some of the Stop Solution bottles, a caustic solution, have been reported to leak". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0224-2020
Classification: Class II
Status: Open, Classified
Initiated: 2018-07-25
Posted: 2019-10-29
Recalling firm: Hycor Biomedical
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.
Product code: DHB System, Test, Radioallergosorbent (Rast) Immunological
Reason for recall: Some of the Stop Solution bottles, a caustic solution, have been reported to leak.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: A Field Safety Notice dated 7/25/2018 was issued via email explaining there have been reports of leakage limited to the Stop Solution bottles, but there is no impact to patient results or performance of the kits.
Quantity in commerce: 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, Kuwait, Netherlands, Russia, Spain, and United Kingdom.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0224-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0224-2020	Class II	Ongoing	Voluntary: Firm initiated	2019-11-06	2019-10-29

Product code DHB

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)