Home / Recalls / Helena Laboratories, Inc. / Z-0529-2019

Z-0529-2019 Class III Terminated

Recalled by Helena Laboratories, Inc. — Beaumont, TX

Recall Details

Product Type
Devices
Report Date
December 12, 2018
Initiation Date
November 7, 2016
Termination Date
January 15, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
43 kits (6 kits Domestic/37 Internationally)

Product Description

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.

Reason for Recall

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

Distribution Pattern

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

Code Information

" 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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