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.

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

On 11/02/2016, the firm, Helena Laboratories, Inc., sent a "Withdrawal Notification" to customers via email. The notice described the product, problem and actions to be taken. The customers were instructed remove lot from inventory and discard; contact technical services at 1-800-231-5663 ext.1600 for MRA#; and complete Withdrawal Notification form and return copy to Helena Laboratories via FAX at:409-842-1874 or email to: [email protected]. The firm is doing a Withdrawal of this lot, and will replace this material, if they have not already done so, with a new kit lot. If the customer indicates how many kits it has remaining, the firm will forward replacement, under Material Return Authorization and to use an enclosed form to report replacement needs. Customers are informed to contact Technical Services is 1-800-231-5663, Ext. 1600; for MRA#, and for questions, to contact Jessica Jones at extension 1177, or email [email protected]. The firm's public contact may be reached at (409)842-3714 extension 1177.