JAS Diagnostics Inc.: Medical Device Recall in 2014 - (Recall #: Z-0827-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: October 23, 2014

Date Posted: December 24, 2014

Recall Number: Z-0827-2015

Event ID: 69622

Reason for Recall:

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

Status: Terminated

Product Quantity: 390

Code Information:

Lot: N0702011K, Exp. 10/2014; N0702012, Exp. 10/2014; N0702013K, Exp. 10/2014; P010201K, Exp. 04/2015; P010202K, Exp. 04/2015; P010203K, Exp. 04/2015; P010204K, Exp. 04/2015; P010205K, Exp. 04/2015; P010206K, Exp. 04/2015; P0402015K, Exp. 07/2015; P0402016K, Exp. 07/2015; P050207K, Exp. 08/2015; P050208K, Exp. 08/2015; P050209K, Exp. 08/2015; P0502010K, Exp. 08/2015; P0502011K, Exp. 08/2015; P0502012K, Exp. 08/2015; P0502013K, Exp. 08/2015; P0502014K, Exp. 08/2015; and P0802017K, Exp. 11/2015.

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated