FDA-Device2014-12-24Class II

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

JAS Diagnostics Inc.
Hazard

Product is not performing according to specifications. Control 2 does not consistently recover within its assigned range.

Sold states
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.
Affected count
390
Manufactured in
14100 Nw 57th Ct, N/A, Miami Lakes, FL, United States
Products
Glucose Hexokinase (Liquid) Reagent For the in vitro quantitative determination of Glucose in serum.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0827-2015

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