HYTEC Stop Solution recall
HYTEC Stop Solution (Allergy), 300ml bottle containing 1N sodium hydroxide solution, Part # 308051, sold separately or as a component contained in the…
Why was HYTEC Stop Solution recalled?
Some of the Stop Solution bottles, a caustic solution, have been reported to leak.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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.
- Product
- HYTEC Stop Solution (Allergy), 300ml bottle containing 1N sodium hydroxide solution, Part # 308051, sold separately or as a component contained in the…
- Recalling firm
- Hycor Biomedical LLC
- Quantity
- 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.
- Recall date
- November 6, 2019
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)