The Recall Desk
HighFDA (Devices)·Z-2351-2021·Announced 2021-09-01

Accu-Chek Aviva Plus Test Strips Recalled for Potential Inaccurate Glucose Readings

Roche Diabetes Care is recalling Accu-Chek Aviva Plus Test Strips because vials may open during shipment, exposing strips to humidity and causing inaccurate glucose readings that could lead to improper treatment decisions.

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: This is an FDA Class II medical device recall for a product with significant potential to harm patients through inaccurate glucose readings affecting therapy decisions. However, there are no reported illnesses or injuries associated with this defect, placing it at High severity rather than Severe.

Plain-English summary

Roche Diabetes Care, Inc. is recalling Accu-Chek Aviva Plus Test Strips, a blood glucose monitoring system. The recalled models are 06908152001, 06908217001, 06908268001, 06908349001, and 06908373001.

Test strip vials may open while inside sealed cartons during shipment. When vials are exposed to humidity, the test strips can become damaged, resulting in inaccurate glucose readings.

Inaccurate test results could lead to inappropriate therapy decisions and adverse health consequences. The recall affects all non-expired lots and applies to products distributed worldwide and across the United States.

The recalled product

Product
Accu-Chek Aviva Plus Test Strip, Blood Glucose Monitoring System, Model numbers: 06908152001, 06908217001, 06908268001, 06908349001, 06908373001
Manufacturer
Roche Diabetes Care, Inc.
Category
Medical Device — Blood Glucose Monitoring
Hazard
  • inaccurate-test-results
  • humidity-damage
  • vial-opening

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 (2)

  • Since this is a labeling correction
  • this recall is not lot specific and is applicable to all non-expired lots.

Distribution

Distributed nationwide across the United States.

Related recalls

Same category