The Recall Desk
ModerateFDA (Devices)·Z-0224-2020·Announced 2019-11-06

Hycor Biomedical Recalls Leaking HYTEC Stop Solution Bottles

Hycor Biomedical is recalling HYTEC Stop Solution bottles that may leak a caustic sodium hydroxide solution. The product is used in specific allergy testing kits.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a caustic solution leaking, which poses a risk of chemical burns, but no specific injuries or illnesses are reported in the source text, fitting the criteria for a moderate severity recall.

Plain-English summary

Hycor Biomedical LLC is recalling HYTEC Stop Solution (Allergy), a 300ml bottle containing 1N sodium hydroxide solution. The recall is being conducted because some of the bottles have been reported to leak. The solution is caustic and is sold separately or as a component in HYTEC Specific/Total IgE EIA kits and HYTEC Specific IgG EIA Kits.

The affected units include 185 individual bottles and 1,298 kits. The Stop Solution bottles were distributed to 12 U.S. states, the U.S. Virgin Islands, and Germany. The assay kits containing the bottles were distributed to Florida and 11 foreign countries. Specific lot numbers and expiration dates for the affected Stop Solution and kits are listed in the official recall notice.

Consumers who have purchased these products should stop using them and contact Hycor Biomedical LLC for further instructions. The recall is classified as Class II by the FDA, indicating a reasonable probability that use of the product could cause temporary or medically reversible health consequences.

The recalled product

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.
Manufacturer
Hycor Biomedical LLC
Category
Medical Device — In Vitro Diagnostics
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (19)

  • 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
  • Lot numbers 154104-10
  • 154104-7
  • 154104-8
  • 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.

Distribution

Distributed in 13 states:

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