HYTEC Stop Solution (Allergy), 300ml bottle containing 1N sodium hydroxide solution, Part # 30805...
FDA Device Recall #Z-0224-2020 — Class II — July 25, 2018
Recall Summary
| Recall Number | Z-0224-2020 |
| Classification | Class II — Moderate risk |
| Date Initiated | July 25, 2018 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Hycor Biomedical LLC |
| Location | Garden Grove, CA |
| Product Type | Devices |
| 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.
Lot / 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.
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.