The Recall Desk
ModerateFDA (Devices)·Z-1942-2021·Announced 2021-06-30

Blood Glucose Test Strips Recalled for Temperature Exposure During Shipping

Cardinal Health is recalling ACCU-CHEK SMARTVIEW 100 test strips distributed in Florida, Georgia, and South Carolina due to temperature excursions during shipping that may cause inaccurate glucose readings.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class II recall with no reported illnesses or injuries. The hazard is theoretical—temperature exposure may cause inaccurate test results but no confirmed harm has been documented. The classification reflects the precautionary nature of this device recall.

Plain-English summary

Cardinal Health Inc. is recalling ACCU-CHEK SMARTVIEW 100 test strips (Item Number 4742862) due to temperature exposure during shipping. Affected devices were exposed to temperatures of 31.9°F intermittently over a 2 hour and 15 minute period, which may cause inaccurate test results.

The recalled product consists of 537 boxes containing 100 strips each. These boxes were distributed in Florida, Georgia, and South Carolina. All affected lots were shipped between February 23, 2011 and March 10, 2021 (NDC/UPC: 365702493100).

Patients and healthcare providers should discontinue use of these test strips if they are in one of the affected states and were purchased during the specified timeframe. Consumers with questions should contact Cardinal Health or consult their healthcare provider. The FDA has not reported any illnesses or injuries related to this recall.

The recalled product

Product
ACCU-CHEK SMARTVIEW 100 TEST STRIPS Item Number: 4742862
Manufacturer
Cardinal Health Inc.
Category
Medical Device — Blood Glucose Test Strips
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)

  • NDC/UPC: 365702493100 All lots shipped from 2/23/201 to 3/10/2021

Distribution

Distributed nationwide across the United States.

The notice also names 3 states specifically:

Part of a larger recall action

This product is one of 14 recalled by Cardinal Health 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 14 products in this recall →

Related recalls

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