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

Recalled December 12, 2018 · FDA recall Z-0529-2019 · Helena Laboratories

Hazard

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

Units

43 kits (6 kits Domestic/37 Internationally)

Sold at

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

Description

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

Product

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.

Manufacturer(s)

Helena Laboratories, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →