ARKRAY Factory, Inc.: SPOTCHEM II Glucose and Basic PANEL-1 Test Strips Recalled for Inaccurate Results

Agency Publication Date: April 22, 2019

Summary

ARKRAY Factory, Inc. is recalling approximately 3,876 boxes of SPOTCHEM II Glucose and SPOTCHEM II Basic PANEL-1 veterinary test strips due to a defect that causes a lowered reaction rate on the glucose reagent pad. These strips are used for testing animal health and were distributed to Illinois in boxes containing 25 individual foil-wrapped strips. If your veterinary practice uses these strips, you should verify the lot numbers on your current stock immediately and contact the manufacturer for guidance on product replacement or disposal.

Risk

The lowered reaction rate can result in falsely low glucose readings for animals being tested. This could lead to a delayed diagnosis or incorrect treatment for serious conditions like diabetes or hypoglycemia, potentially harming the animal's health.

What You Should Do

Check your inventory for SPOTCHEM II Glucose Test Strips (Catalog No. SE77130 / Henry Schein No. 056138) with Lot No. EA7D15 (Exp. 04/30/2018), Lot No. EA7E16 (Exp. 05/31/18), or Lot No. EA7J22 (Exp. 09/30/18).
Check your inventory for SPOTCHEM II Basic PANEL-1 Test Strips (Catalog No. SE77159 / Henry Schein No. 056126) with Lot No. PL7C29 (Exp. 3/31/18), Lot No. PL7D31 (Exp. 4/24/18), Lot No. PL7E32 (Exp. 5/22/18), or Lot No. PL7F33 (Exp. 6/30/18).
Immediately stop using any test strips from the affected lot numbers to ensure diagnostic accuracy for your patients.
Contact your healthcare provider or ARKRAY Factory, Inc. at their facility in Koka-Shi, Japan, or your local distributor for further instructions on returning the product or obtaining a replacement.
For additional questions regarding this recall, contact the FDA's Center for Veterinary Medicine at 240-402-7002.

Your Remedy Options

Other Action

Manufacturer notification and guidance

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: SPOTCHEM II Glucose Test Strip (25 strips per box)

Model:

SE77130

056138

Lot Numbers:

EA7D15 (Exp. Date 04/30/2018)

EA7E16 (Exp. Date 05/31/18)

EA7J22 (Exp. Date 09/30/18)

Date Ranges: Exp. Date 04/30/2018, Exp. Date 05/31/18, Exp. Date 09/30/18

Product: SPOTCHEM II Basic PANEL-1 Test Strip (25 strips per box)

Model:

SE77159

056126

Lot Numbers:

PL7C29 (Exp. Date 3/31/18)

PL7D31 (Exp. Date 4/24/18)

PL7E32 (Exp. Date 5/22/18)

PL7F33 (Exp. Date 6/30/18)

Date Ranges: Exp. Date 3/31/18, Exp. Date 4/24/18, Exp. Date 5/22/18, Exp. Date 6/30/18

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 79833

Status: Active

Manufacturer: ARKRAY Factory, Inc.

Sold By: Henry Schein Animal Health

Manufactured In: Japan

Units Affected: 2 products (90 boxes (25 strips per box); 3,786 boxes (25 strips per box))

Distributed To: Illinois

Agency Last Updated: January 21, 2020

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

Summary

What You Should Do

Check your inventory for SPOTCHEM II Glucose Test Strips (Catalog No. SE77130 / Henry Schein No. 056138) with Lot No. EA7D15 (Exp. 04/30/2018), Lot No. EA7E16 (Exp. 05/31/18), or Lot No. EA7J22 (Exp. 09/30/18).

Check your inventory for SPOTCHEM II Basic PANEL-1 Test Strips (Catalog No. SE77159 / Henry Schein No. 056126) with Lot No. PL7C29 (Exp. 3/31/18), Lot No. PL7D31 (Exp. 4/24/18), Lot No. PL7E32 (Exp. 5/22/18), or Lot No. PL7F33 (Exp. 6/30/18).

Immediately stop using any test strips from the affected lot numbers to ensure diagnostic accuracy for your patients.

Contact your healthcare provider or ARKRAY Factory, Inc. at their facility in Koka-Shi, Japan, or your local distributor for further instructions on returning the product or obtaining a replacement.

For additional questions regarding this recall, contact the FDA's Center for Veterinary Medicine at 240-402-7002.

Affected Products

Product: SPOTCHEM II Glucose Test Strip (25 strips per box)

Model:

SE77130

056138

Lot Numbers:

EA7D15 (Exp. Date 04/30/2018)

EA7E16 (Exp. Date 05/31/18)

EA7J22 (Exp. Date 09/30/18)

Date Ranges: Exp. Date 04/30/2018, Exp. Date 05/31/18, Exp. Date 09/30/18

Product: SPOTCHEM II Basic PANEL-1 Test Strip (25 strips per box)

Model:

SE77159

056126

Lot Numbers:

PL7C29 (Exp. Date 3/31/18)

PL7D31 (Exp. Date 4/24/18)

PL7E32 (Exp. Date 5/22/18)

PL7F33 (Exp. Date 6/30/18)

Date Ranges: Exp. Date 3/31/18, Exp. Date 4/24/18, Exp. Date 5/22/18, Exp. Date 6/30/18

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 79833

Status: Active

Manufacturer: ARKRAY Factory, Inc.

Sold By: Henry Schein Animal Health

Manufactured In: Japan

Units Affected: 2 products (90 boxes (25 strips per box); 3,786 boxes (25 strips per box))

Distributed To: Illinois

Agency Last Updated: January 21, 2020