Reported Nov 6, 2019 · Ongoing

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

Hycor Biomedical LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Hycor Biomedical LLC · 7272 Chapman Ave · Garden Grove, CA · 92841-2103

Is this the product you have?

  • 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
Lot codes and dates

9 of 9 products

Products covered by this recall
Model / numberProduct as published
308051Stop Solution bottles, - Lot numbers 154803, exp. 31-MAR-2021
and 154144, exp. 30-SEP-2020
74155HYTEC Specific & Total IgE Kit, , Lot numbers 154104-11, exp. 30-SEP-2018
and 156932-1, exp. 30-JUN-2018 - all contain Stop Solution lot 154803
74155HYTEC Specific & Total IgE Kit, , 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
74114and HYTEC Specific IgG EIA , Lot number 155324, exp. 31-DEC-2018 - contains Stop Solution lot 154144.
Amount recalled
185 individual bottles (170 US and 15 OUS) and 1,298/1-bottle kits (OUS)

Where it was sold

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:58 PM UTC

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