Helena Laboratories, Inc.: Medical Device Recall in 2018 - (Recall #: Z-0529-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

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.

Product Classification:

Class III

Date Initiated: November 7, 2016

Date Posted: December 12, 2018

Recall Number: Z-0529-2019

Event ID: 81303

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.

Status: Terminated

Product Quantity: 43 kits (6 kits Domestic/37 Internationally)

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

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated