CLASS II ONGOING Device recall · Reported 6 Nov 2019 · FDA Enforcement Report

Hytec Stop Solution (Allergy) bottle recalled by Hycor Biomedical

Hycor Biomedical is recalling Hytec Stop Solution (Allergy) bottle containing 1N sodium hydroxide solution, Part #, distributed in 12 states. The recall was initiated on 25 Jul 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesStop 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.

Quantity recalled185 individual bottles (170 US and 15 OUS) and 1,298/1-bottle kits (OUS)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0224-2020
FDA event ID: 83853
Recalling firm: Hycor Biomedical, Garden Grove, CA
Classification: Class II
Status: Ongoing
Recall initiated: 25 Jul 2018
FDA classified: 29 Oct 2019
Reported: 6 Nov 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Other Medical Devices

Timeline

25 Jul 2018	Recall initiated by company
29 Oct 2019	Classified by FDA	+461 days
6 Nov 2019	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Some of the Stop Solution bottles, a caustic solution, have been reported to leak.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

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.

Where it was distributed

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.

Alabama California Florida Illinois Kansas Louisiana Mississippi New Jersey New York South Carolina Texas Washington

Questions about this recall

Is Hytec Stop Solution (Allergy) bottle containing 1N sodium hydroxide solution, Part # recalled?

Yes. Hycor Biomedical recalled Hytec Stop Solution (Allergy) bottle containing 1N sodium hydroxide solution, Part # on 25 Jul 2018. The recall is Class II and its status is Ongoing. Recall number Z-0224-2020.

Why was it recalled?

Some of the Stop Solution bottles, a caustic solution, have been reported to leak.

Which lots are affected?

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.

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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