medical Class III Updated 2018-12-12

Helena Laboratories, Inc. recalls Gel Alkaline Phosphatase Isoenzyme Control Kit: Gel Alkal

Recalled 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.

Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: " Lot Codes: 1-16-5104 (Scheme: 1(st lot)-(of 20)16-(for C/N )5104) " Model/Catalog Number: 5104 " UDI: Primary DI - M52551040
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