FDAFDA · Food and drugs·Recall number Z-0529-2019
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.
Published December 12, 2018 · Recall initiated: November 7, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Due to a customer experiencing complaints on bone fraction of assay not being in range. The complaint: ~12% lower enzyme activity was noted.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Helena Laboratories, Inc.
- Distributor
- Worldwide Distribution: US (nationwide) to states of: GA, IN, and MI, and countries of: Australia, Brazil, Canada, Japan and Hong Kong.
- Lot
- " Lot Codes: 1-16-5104 (Scheme: 1(st lot)-(of 20)16-(for C/N )5104) " Model/Catalog Number: 5104 " UDI: Primary DI - M52551040
- Risk classification
- Class III
- Area (FDA)
- device
- Country
- United States
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