Recall Z-0224-2020— Hycor Biomedical LLC

Name: FDA recall Z-0224-2020
Creator: U.S. Food and Drug Administration
Published: 2018-07-25

Class II · Ongoing

Class II FDA medical device recall by Hycor Biomedical LLC, initiated 2018-07-25. It names 2 FDA 510(k) clearances: K081217, K941278. 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..

Recalling firm: Hycor Biomedical LLC
Classification: Class II
Status: Ongoing
Initiated: 2018-07-25
Firm location: Garden Grove, CA, United States

510(k) clearances named in this recall

2 on FDA's record

K081217 — HY-TEC SPECIFIC AND TOTAL IGE EIA SYSTEMHycor Biomedical, Inc.·cleared 2008-05-22
K941278 — HY-TEC AUTOMATED EIA SYSTEMHycor Biomedical, Inc.·cleared 1995-03-13

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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 for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.