Recall Z-0529-2019 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
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.
| Date | Nov 7, 2016 |
| Status | Terminated |
| 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 indic |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K895528 | GEL ALKALINE PHOSPHATASE ISOENZYME CONTROL NO.5104 Helena Laboratories, Oct 25, 1989 |