Home / Recalls / Hycor Biomedical LLC / Z-0224-2020

Z-0224-2020 Class II Ongoing

Recalled by Hycor Biomedical LLC — Garden Grove, CA

FDA device recall Z-0224-2020 was initiated by Hycor Biomedical LLC on July 25, 2018 and is designated Class II. Reason for recall: Some of the Stop Solution bottles, a caustic solution, have been reported to leak. The recall status is ongoing. Affected quantity: 185 individual bottles (170 US and 15 OUS) and 1,298/1-bottle kits (OUS).

Recall Details

Product Type: Devices
Report Date: November 6, 2019
Initiation Date: July 25, 2018
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 185 individual bottles (170 US and 15 OUS) and 1,298/1-bottle kits (OUS)

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.

Distribution Pattern

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.

Code Information

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.