FDA Medical Device Recalls (openFDA)
Helena Laboratories, Inc.: 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.
- Recall number
- Z-0529-2019
- Recalling firm
- Helena Laboratories, Inc.
- 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.
- Status
- Terminated
- Initiated
- 2016-11-07
- Posted
- not on file
- Terminated
- 2021-01-15
- Reason
- Due to a customer experiencing complaints on bone fraction of assay not being in range. The complaint: ~12% lower enzyme activity was noted.
- 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: jjones@helena.com. 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 jjones@helena.com. The firm's public contact may be reached at (409)842-3714 extension 1177.
- Quantity
- 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.
- Lot, serial or model codes
- " Lot Codes: 1-16-5104 (Scheme: 1(st lot)-(of 20)16-(for C/N )5104) " Model/Catalog Number: 5104 " UDI: Primary DI - M52551040
- 510(k) numbers
- ["K895528"]
- PMA numbers
- not on file
- Product code
- JJX
- Firm FEI
- 1618982
- Firm city
- Beaumont
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28