Arkray Factory USA, Inc.: Medical Device Recall in 2016 - (Recall #: Z-0630-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

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.

Product Classification:

Class I

Date Initiated: December 18, 2015

Date Posted: January 27, 2016

Recall Number: Z-0630-2016

Event ID: 72860

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.

Status: Terminated

Product Quantity: 88 boxes (25 foil packaged test strips per box)

Code Information:

Lot Number EA4M78

Distribution Pattern:

Distributed in the states of FL, IL, KY, MI, NC, NY, OH, and TN.

Voluntary or Mandated:

Voluntary: Firm initiated