Recall Z-0827-2015— JAS Diagnostics Inc.

Name: FDA recall Z-0827-2015
Creator: U.S. Food and Drug Administration
Published: 2014-10-23

Class II · Terminated

Class II FDA medical device recall by JAS Diagnostics Inc., initiated 2014-10-23, terminated 2015-02-26. It names one FDA 510(k) clearance: K011900. Product: Glucose Hexokinase (Liquid) Reagent For the in vitro quantitative determination of Glucose in serum.. Reason: Product is not performing according to specifications. Control 2 does not consistently recover within its assigned range..

Recalling firm: JAS Diagnostics Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-10-23
Terminated: 2015-02-26
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

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

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