FDAClass IIDecember 24, 2014

Glucose Hexokinase recall

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

Why was Glucose Hexokinase recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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.

Product
Glucose Hexokinase (Liquid) Reagent For the in vitro quantitative determination of Glucose in serum.
Recalling firm
JAS Diagnostics Inc.
Quantity
390
Distribution
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.
Recall date
December 24, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls