FDAFDA · Food and drugs·Recall number Z-1873-2014
Glucose Hexokinase Liquid Reagent For the in vitro quantitative determination of Glucose in serum.
Published July 2, 2014 · Recall initiated: April 7, 2014
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
JAS Diagnostics, Inc. of Miami Lakes, FL is recalling their Glucose Hexokinase reagent due to certain lots not performing according to their specifications.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- JAS Diagnostics Inc.
- Distributor
- Worldwide Distribution - US including Puerto Rico and the states of CA, FL, TX, PA, GA, KY, MI, NY, OK, MN, TN, VA, NC, NV, NJ and WV, and the countries of Barbados, Ghana, Trinidad, Tobago, Canada and Haiti.
- Lot
- LOTS#: N060208K, N060209K, N0602010K, N0902014K, N0902015K, N0902016K, N0902017K, N0902018K, N0902019K, N0902020K, N1102021K, N1102022K, N1102023K, N1102024K, N1102025K, N1102026K, N1102027K, N1102028K, N1102029K.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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