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 Basic Panel - 1 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 Basic Panel - 1 Reagent test strips, Product # 11726, MEDTEST DX Catalog # 77484. Calcium, Blood Urea Nitrogen, Glucose, Albumin, Creatinine. For the in vitro quantitative determination of calcium, blood urea nitrogen (BUN), glucose, albumin, and creatinine.

Quantity: 11 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