Recall Z-0630-2016— Arkray Factory USA, Inc.

Name: FDA recall Z-0630-2016
Creator: U.S. Food and Drug Administration
Published: 2015-12-18

Class I · Terminated

Class I FDA medical device recall by Arkray Factory USA, Inc., initiated 2015-12-18, terminated 2017-01-04. It names one FDA 510(k) clearance: K041427. 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.. Reason: 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..

Recalling firm: Arkray Factory USA, Inc.
Classification: Class I
Status: Terminated
Initiated: 2015-12-18
Terminated: 2017-01-04
Firm location: Minneapolis, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K041427 — THE POLYMEDCO SPOTCHEM EX GLUCOSE, FRUCTOSAMINE AND AST TESTSArkray, Inc.·cleared 2004-11-24

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.