Z-1873-2014 Class II Terminated
FDA device recall Z-1873-2014 was initiated by JAS Diagnostics Inc. on April 7, 2014 and is designated Class II. 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. The recall status is terminated (terminated August 21, 2014). Affected quantity: 407.
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.