Device product
Glucose Hexokinase Liquid Reagent For the in vitro quantitative determination of Glucose in serum.
Z-1873-2014
Product summary
- Event
- Event 68343
- Status
- Terminated
- Classification
- Class II
- Quantity
- 407
- Official record key
device-enforcement:Z-1873-2014
Official wording
Reason: JAS Diagnostics, Inc. of Miami Lakes, FL is recalling their Glucose Hexokinase reagent due to certain lots not performing according to their specifications.
Code information: LOTS#: N060208K, N060209K, N0602010K, N0902014K, N0902015K, N0902016K, N0902017K, N0902018K, N0902019K, N0902020K, N1102021K, N1102022K, N1102023K, N1102024K, N1102025K, N1102026K, N1102027K, N1102028K, N1102029K.
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.
Derived failure modes
-
Unknown
JAS Diagnostics, Inc. of Miami Lakes, FL is recalling their Glucose Hexokinase reagent due to certain lots not performing according to their specifications.