Recall Z-1873-2014— JAS Diagnostics Inc.

Name: FDA recall Z-1873-2014
Creator: U.S. Food and Drug Administration
Published: 2014-04-07

Class II · Terminated

Class II FDA medical device recall by JAS Diagnostics Inc., initiated 2014-04-07, terminated 2014-08-21. It names one FDA 510(k) clearance: K011900. Product: Glucose Hexokinase Liquid Reagent For the in vitro quantitative determination of Glucose in serum.. Reason: JAS Diagnostics, Inc. of Miami Lakes, FL is recalling their Glucose Hexokinase reagent due to certain lots not performing according to their specifications..

Recalling firm: JAS Diagnostics Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-04-07
Terminated: 2014-08-21
Firm location: Miami Lakes, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K011900 — GLUCOSE (HEXOKINASE)Jas Diagnostics, Inc.·cleared 2001-07-31

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.