Skip to content
Recall Observatory FDA recall evidence

Device product

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

Z-1873-2014

April 07, 2014

Class II

Product summary

Firm
JAS Diagnostics Inc.
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

    reason.no_named_rule · v1.0.0

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