The Recall Desk
HighFDA (Devices)·Z-0630-2016·Announced 2016-01-27

Arkray SPOTCHEM II Glucose Reagent Test Strips Recalled for Inaccurate Results

Arkray Factory USA, Inc. is recalling SPOTCHEM II Glucose Reagent Test Strips because a lowered reaction rate causes inaccurate high glucose readings.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device defect that leads to inaccurate diagnostic results, posing a risk of harm through misdiagnosis or delayed treatment, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

Arkray Factory USA, Inc. is recalling one lot of SPOTCHEM II Glucose Reagent Test Strips (Item No. 77101, MEDTEST DX Catalog # 77424) and one lot of SPOTCHEM II Basic PANEL-1 Reagent Test Strips. The recall is due to a lowered reaction rate in the glucose reagent pad. The affected lot number is EA4M78. The product is used for the in vitro quantitative determination of glucose in human plasma from whole blood samples.

The defect causes the test strips to display a result of approximately 300 to 400 mg/dL for any glucose value that exceeds the upper limit of 416 mg/dL. This means that patients with very high blood glucose levels may receive a falsely low reading, which could impact clinical decision-making.

The affected units were distributed in the states of Florida, Illinois, Kentucky, Michigan, North Carolina, New York, Ohio, and Tennessee. A total of 88 boxes (25 foil packaged test strips per box) are involved. Healthcare providers and patients should stop using the affected test strips and contact Arkray Factory USA, Inc. for further instructions.

The recalled product

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.
Manufacturer
Arkray Factory USA, Inc.
Category
Medical Device — In Vitro Diagnostics
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot Number EA4M78

Distribution

Distributed in 8 states:

Part of a larger recall action

This product is one of 2 recalled by Arkray Factory USA, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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