Z-0827-2015 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- December 24, 2014
- Initiation Date
- October 23, 2014
- Termination Date
- February 26, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 390
Product Description
Glucose Hexokinase (Liquid) Reagent For the in vitro quantitative determination of Glucose in serum.
Reason for Recall
Product is not performing according to specifications. Control 2 does not consistently recover within its assigned range.
Distribution Pattern
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.
Code Information
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.