Z-0630-2016Class I

arkray SPOTCHEM II Glucose Reagent test strips, Item No. 77101, MEDTEST DX Catalog # 77424. For the in vitro...

Name: Z-0630-2016 arkray SPOTCHEM II Glucose Reagent test strips, Item No. 77101, MEDTEST DX Catalog # 77424. For the in vitro...
Creator: Arkray Factory USA, Inc.
Published: 2015-12-18
License: https://open.fda.gov/license/

Arkray Factory USA, Inc. / initiated 2015-12-18 / Terminated / root cause: design

FDA source

Arkray Factory USA, Inc. began a recall of arkray SPOTCHEM II Glucose Reagent test strips, Item No. 77101, MEDTEST DX Catalog # 77424. For the in vitro quantitative determination of glucose in human... on 2015-12-18. FDA classified it as Class I and gives the reason as "One lot each of SPOTCHEM II Basic PANEL-1 Reagent Test Strip and SPOTCHEM II Glucose Reagent Test Strip are being recalled due to a lowered reaction rate in the reagent pad for glucose. The affected lots will display a...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0630-2016
Classification: Class I
Status: Terminated
Initiated: 2015-12-18
Posted: 2016-01-15
Terminated: 2017-01-04
Recalling firm: Arkray Factory USA, Inc.
Product: arkray SPOTCHEM II Glucose Reagent test strips, Item No. 77101, MEDTEST DX Catalog # 77424. For the in vitro quantitative determination of glucose in human plasma from whole blood samples.
Product code: CGA Glucose Oxidase, Glucose
Reason for recall: One lot each of SPOTCHEM II Basic PANEL-1 Reagent Test Strip and SPOTCHEM II Glucose Reagent Test Strip are being recalled due to a lowered reaction rate in the reagent pad for glucose. The affected lots will display a result of approximately 300 to 400 mg/dL for any glucose value that exceeds the upper limit of 416 mg/dL.
Root cause tag: design
FDA root cause: Component design/selection
Action: The firm sent an Urgent Medical Device Recall letter to customers beginning 12/18/2015. The letter identified affected product, stated the reason for recall and asked for unused product to be returned. For instructions on returning unused product contact Lesty Jaranilla 1-877-538-8872 x3243.
Quantity in commerce: 88 boxes (25 foil packaged test strips per box)
Distribution: Distributed in the states of FL, IL, KY, MI, NC, NY, OH, and TN.
Product codes and lots: Lot Number EA4M78

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0630-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0630-2016	Class I	Terminated	Voluntary: Firm initiated	2016-01-27	2016-01-15
Z-0631-2016	Class I	Terminated	Voluntary: Firm initiated	2016-01-27	2016-01-15

Product code CGA

K041427Class IIThe Polymedco Spotchem Ex Glucose, Fructosamine and Ast TestsArkray, Inc. / cleared 2004-11-24

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)