FDA-Device2019-11-13Class III
SPIFE Alkaline Hemoglobin Kit, Cat. No. 3415, for use in the separation and quantitation of hemoglobins by agarose electrophoresis using the SPIFE systems
Helena Laboratories, Corp.
Hazard
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.
Sold states
US: OH, NY, MI, IN, IL, MS, TX, CT, NJ, KY, FL, MD, GA, PA, AZ, MO, VA, SC, LA, KS, WA, WI, OUS: Colombia, Brasil, Taiwan
Affected count
899 kits
Manufactured in
1530 Lindbergh Dr, N/A, Beaumont, TX, United States
Products
SPIFE Alkaline Hemoglobin Kit, Cat. No. 3415, for use in the separation and quantitation of hemoglobins by agarose electrophoresis using the SPIFE systems
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0297-2020Don't want to check this manually?
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