Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
SPIFE Alkaline Hemoglobin Kit Recalled by Helena Laboratories, Corp. Due to Lots of gel kits contained a newer revision...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Helena Laboratories, Corp. directly.
Affected Products
SPIFE Alkaline Hemoglobin Kit, Cat. No. 3415, for use in the separation and quantitation of hemoglobins by agarose electrophoresis using the SPIFE systems
Quantity: 899 kits
Why Was This Recalled?
Lots of gel kits contained a newer revision of the Customer Procedures instructions than intended. The incorrect inserts refer to updated parameters associated with new electrodes -- which have not yet been made available to users.
Where Was This Sold?
This product was distributed to 22 states: AZ, CT, FL, GA, IL, IN, KS, KY, LA, MD, MI, MS, MO, NJ, NY, OH, PA, SC, TX, VA, WA, WI
About Helena Laboratories, Corp.
Helena Laboratories, Corp. has 11 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report