Helena Laboratories, Corp. recalls SPIFE Alkaline Hemoglobin Kit, Cat. No. 3415, for use in the separation and quantitation of hemoglobins by agarose elec…

Recall date

February 27, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0297-2020

FDA classification

Class III

Brand / firm

Helena Laboratories, Corp.

Sold / distributed

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

Why it was 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.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

SPIFE Alkaline Hemoglobin Kit, Cat. No. 3415, for use in the separation and quantitation of hemoglobins by agarose electrophoresis using the SPIFE systems