Z-0529-2019Class III

Gel Alkaline Phosphatase Isoenzyme Control Kit: Gel Alkaline Phosphatase Isoenzyme Control Cat. No. 5104 1 x...

Name: Z-0529-2019 Gel Alkaline Phosphatase Isoenzyme Control Kit: Gel Alkaline Phosphatase Isoenzyme Control Cat. No. 5104 1 x...
Creator: Helena Laboratories, Inc.
Published: 2016-11-07
License: https://open.fda.gov/license/

Helena Laboratories, Corp. / initiated 2016-11-07 / Terminated

FDA source

Helena Laboratories, Inc. began a recall of 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... on 2016-11-07. FDA classified it as Class III and gives the reason as "Due to a customer experiencing complaints on bone fraction of assay not being in range. The complaint: ~12% lower enzyme activity was noted". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0529-2019
Classification: Class III
Status: Terminated
Initiated: 2016-11-07
Posted: 2018-11-30
Terminated: 2021-01-15
Recalling firm: Helena Laboratories, Corp.
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.
Product code: JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
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.
FDA root cause: Unknown/Undetermined by firm
Action: 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.
Quantity in commerce: 43 kits (6 kits Domestic/37 Internationally)
Distribution: Worldwide Distribution: US (nationwide) to states of: GA, IN, and MI, and countries of: Australia, Brazil, Canada, Japan and Hong Kong.
Product codes and lots: " Lot Codes: 1-16-5104 (Scheme: 1(st lot)-(of 20)16-(for C/N )5104) " Model/Catalog Number: 5104 " UDI: Primary DI - M52551040

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0529-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0529-2019	Class III	Terminated	Voluntary: Firm initiated	2018-12-12	2018-11-30

Product code JJX

K895528Class IGel Alkaline Phosphatase Isoenzyme Control No.5104Helena Laboratories / cleared 1989-10-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)