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.
FDA Recall Z-0224-2020 · Posted None
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Recalling FirmHycor Biomedical LLC
Recall StatusOpen, Classified
Product CodeDHB
Date Initiated2018-07-25
Product Quantity185 individual bottles (170 US and 15 OUS) and 1,298/1-bottle kits (OUS)
Reason for Recall
Some of the Stop Solution bottles, a caustic solution, have been reported to leak.
Firm 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.
Root Cause
Employee error
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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