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U.S. Department of Health and Human Services

Class 2 Device Recall HYTEC Specific & Total IgE Kit

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  Class 2 Device Recall HYTEC Specific & Total IgE Kit see related information
Date Initiated by Firm July 25, 2018
Create Date October 29, 2019
Recall Status1 Open3, Classified
Recall Number Z-0224-2020
Recall Event ID 83853
510(K)Number K081217  K941278  
Product Classification System, test, radioallergosorbent (rast) immunological - Product Code DHB
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.
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.  
Recalling Firm/
Manufacturer		 Hycor Biomedical LLC
7272 Chapman Ave
Garden Grove CA 92841-2103
For Additional Information Contact Ms. Tara Viviani, RAC (US)
714-933-3000
Manufacturer Reason
for Recall		 Some of the Stop Solution bottles, a caustic solution, have been reported to leak.
FDA Determined
Cause 2		 Employee error
Action A Field Safety Notice dated 7/25/2018 was issued via email explaining there have been reports of leakage limited to the Stop Solution bottles, but there is no impact to patient results or performance of the kits.
Quantity in Commerce 185 individual bottles (170 US and 15 OUS) and 1,298/1-bottle kits (OUS)
Distribution 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = DHB and Original Applicant = HYCOR BIOMEDICAL, INC.
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