Z-1873-2014 Class II Terminated

Recalled by JAS Diagnostics Inc. — Miami Lakes, FL

Recall Details

Product Type
Devices
Report Date
July 2, 2014
Initiation Date
April 7, 2014
Termination Date
August 21, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
407

Product Description

Glucose Hexokinase Liquid Reagent For the in vitro quantitative determination of Glucose in serum.

Reason for Recall

JAS Diagnostics, Inc. of Miami Lakes, FL is recalling their Glucose Hexokinase reagent due to certain lots not performing according to their specifications.

Distribution Pattern

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.

Code Information

LOTS#: N060208K, N060209K, N0602010K, N0902014K, N0902015K, N0902016K, N0902017K, N0902018K, N0902019K, N0902020K, N1102021K, N1102022K, N1102023K, N1102024K, N1102025K, N1102026K, N1102027K, N1102028K, N1102029K.