Z-0827-2015Class II

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

Name: Z-0827-2015 Glucose Hexokinase (Liquid) Reagent For the in vitro quantitative determination of Glucose in serum
Creator: JAS Diagnostics Inc.
Published: 2014-10-23
License: https://open.fda.gov/license/

JAS Diagnostics/Drew Scientific / initiated 2014-10-23 / Terminated

FDA source

JAS Diagnostics Inc. began a recall of Glucose Hexokinase (Liquid) Reagent For the in vitro quantitative determination of Glucose in serum on 2014-10-23. FDA classified it as Class II and gives the reason as "Product is not performing according to specifications. Control 2 does not consistently recover within its assigned range". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0827-2015
Classification: Class II
Status: Terminated
Initiated: 2014-10-23
Posted: 2014-12-18
Terminated: 2015-02-26
Recalling firm: JAS Diagnostics/Drew Scientific
Product: Glucose Hexokinase (Liquid) Reagent For the in vitro quantitative determination of Glucose in serum.
Product code: CFR Hexokinase, Glucose
Reason for recall: Product is not performing according to specifications. Control 2 does not consistently recover within its assigned range.
FDA root cause: Under Investigation by firm
Action: On October 23, 2014, JAS Diagnostics, Inc. sent out an IMPORTANT PRODUCT RECALL INFORMATION letter asking its consignees to discontinue use of the Glucose Hexokinase lots immediately. Customers are to contact the Service Department at 305-748-2762 or 305-748-2763 for information regarding reimbursement. Also, customers are to complete the attached Certificate of Destruction and return the document to JAS Diagnostics.
Quantity in commerce: 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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0827-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0827-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17

Product code CFR

K011900Class IIGlucose (Hexokinase)Jas Diagnostics, Inc. / cleared 2001-07-31

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)