FDAFDA · Food and drugs·Recall number Z-0827-2015
Glucose Hexokinase (Liquid) Reagent For the in vitro quantitative determination of Glucose in serum.
Published December 24, 2014 · Recall initiated: October 23, 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
Product is not performing according to specifications. Control 2 does not consistently recover within its assigned range.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- JAS Diagnostics Inc.
- Distributor
- Worldwide Distribution -- US, including the states of NV, TN, TX, FL, GA, NY, NC, CA, MN, OR and Puerto Rico; and, the countries of France, Jamaica, Haiti, Cayman Islands, Trinidad & Tobago, and Ghana.
- Lot
- Lot: N0702011K, Exp. 10/2014; N0702012, Exp. 10/2014; N0702013K, Exp. 10/2014; P010201K, Exp. 04/2015; P010202K, Exp. 04/2015; P010203K, Exp. 04/2015; P010204K, Exp. 04/2015; P010205K, Exp. 04/2015; P010206K, Exp. 04/2015; P0402015K, Exp. 07/2015; P0402016K, Exp. 07/2015; P050207K, Exp. 08/2015; P050208K, Exp. 08/2015; P050209K, Exp. 08/2015; P0502010K, Exp. 08/2015; P0502011K, Exp. 08/2015; P0502012K, Exp. 08/2015; P0502013K, Exp. 08/2015; P0502014K, Exp. 08/2015; and P0802017K, Exp. 11/2015.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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