Class I — Serious Health Hazard

Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.

arkray SPOTCHEM II Glucose Reagent test strips Recalled by Arkray Factory USA, Inc. Due to One lot each of SPOTCHEM II Basic PANEL-1...

Date: December 18, 2015
Company: Arkray Factory USA, Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Arkray Factory USA, Inc. directly.

Affected Products

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.

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

Why Was This Recalled?

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.

Where Was This Sold?

This product was distributed to 8 states: FL, IL, KY, MI, NY, NC, OH, TN

Affected (8 states)Not affected

About Arkray Factory USA, Inc.

Arkray Factory USA, Inc. has 3 total recalls tracked by RecallDetector.

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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report