The Recall Desk
HighFDA (Devices)·Z-2352-2021·Announced 2021-09-01

Accu-Chek Performa Test Strips Recalled Due to Defective Packaging

Roche Diabetes Care is recalling Accu-Chek Performa test strips because vials may open during shipment, exposing strips to humidity and causing inaccurate glucose readings that could lead to inappropriate diabetes 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 a Class II recall of a risk-of-harm product (blood glucose test strips) where defective packaging could result in inaccurate readings leading to inappropriate therapy decisions. No illnesses or injuries have been reported.

Plain-English summary

Roche Diabetes Care, Inc. is recalling Accu-Chek Performa Test Strips (Model 07299702001) nationwide and worldwide because test strip vials may open while inside sealed cartons during shipment.

When vials open, test strips are exposed to humidity, which damages them and results in inaccurate blood glucose readings. Inaccurate test results could lead to inappropriate therapy decisions and adverse health consequences for patients with diabetes.

Consumers should stop using affected test strips and contact their healthcare provider or Roche Diabetes Care for guidance on replacement or alternative testing methods. Those who have been using affected strips should consult their healthcare provider about their blood glucose readings and any treatment adjustments that may be necessary.

The recalled product

Product
Accu-Chek Performa Test Strip, Blood Glucose Monitoring System, Model number 07299702001
Manufacturer
Roche Diabetes Care, Inc.
Category
Medical Device — Blood Glucose Monitoring
Hazard
  • defective-packaging
  • humidity-damage
  • inaccurate-readings

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