Z-1873-2014Class II

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

Name: Z-1873-2014 Glucose Hexokinase Liquid Reagent For the in vitro quantitative determination of Glucose in serum
Creator: JAS Diagnostics Inc.
Published: 2014-04-07
License: https://open.fda.gov/license/

JAS Diagnostics/Drew Scientific / initiated 2014-04-07 / 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 2014-04-07. FDA classified it as Class II and gives the reason as "JAS Diagnostics, Inc. of Miami Lakes, FL is recalling their Glucose Hexokinase reagent due to certain lots not performing according to their specifications". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1873-2014
Classification: Class II
Status: Terminated
Initiated: 2014-04-07
Posted: 2014-06-25
Terminated: 2014-08-21
Recalling firm: JAS Diagnostics/Drew Scientific
Product: Glucose Hexokinase Liquid Reagent For the in vitro quantitative determination of Glucose in serum.
Product code: CGA Glucose Oxidase, Glucose
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.
FDA root cause: Mixed-up of materials/components
Action: JAS Diagnostics, Inc. sent an Important Product Recall Information letter dated April 7, 2014 to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The customers were instructed to: 1) Screen their inventory for any of the lots listed in the letter and discontinue use immediately. 2) Contact the Customer Service Department at 305-748-2762 or 305-748-2763 to obtain replacement product.
Quantity in commerce: 407
Distribution: Worldwide Distribution - US including Puerto Rico and the states of CA, FL, TX, PA, GA, KY, MI, NY, OK, MN, TN, VA, NC, NV, NJ and WV, and the countries of Barbados, Ghana, Trinidad, Tobago, Canada and Haiti.
Product codes and lots: LOTS#: N060208K, N060209K, N0602010K, N0902014K, N0902015K, N0902016K, N0902017K, N0902018K, N0902019K, N0902020K, N1102021K, N1102022K, N1102023K, N1102024K, N1102025K, N1102026K, N1102027K, N1102028K, N1102029K.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1873-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1873-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-02	2014-06-25

Product code CGA

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)