Helena Laboratories, Inc. recalls Gel Alkaline Phosphatase Isoenzyme Control Kit: Gel Alkaline Phosphatase Isoenzyme Control Cat. No. 5104 1 x 2.0 mL FOR…

Recall date

November 7, 2016

Source

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

Recall number

Z-0529-2019

FDA classification

Class III

Brand / firm

Helena Laboratories, Inc.

Sold / distributed

Worldwide Distribution: US (nationwide) to states of: GA, IN, and MI, and countries of: Australia, Brazil, Canada, Japan and Hong Kong.

Why it was recalled

Due to a customer experiencing complaints on bone fraction of assay not being in range. The complaint: ~12% lower enzyme activity was noted.

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

What was recalled

Gel Alkaline Phosphatase Isoenzyme Control Kit: Gel Alkaline Phosphatase Isoenzyme Control Cat. No. 5104 1 x 2.0 mL FOR IN-VITRO DIAGNOSTIC USE Gel Alkaline Phosphatase Isoenzyme Control 20mL 001831 Alkaline Phosphatase Isoenzyme Control is to be used as a qualitative and/or quantitative control to aid in the identification of alkaline Phosphatase isoenzymes by electrophoresis.