Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Accu-Chek Performa Test Strip Recalled by Roche Diabetes Care, Inc. Due to Test strip vials may open while inside sealed...

Date: July 28, 2021
Company: Roche Diabetes Care, Inc.
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Roche Diabetes Care, Inc. directly.

Affected Products

Accu-Chek Performa Test Strip, Blood Glucose Monitoring System, Model number 07299702001

Quantity: 146,854 (US); 59,815,555 (OUS)

Why Was This Recalled?

Test strip vials may open while inside sealed cartons during shipment. An open vial might expose the test strips to humidity, which might damage the strips and result in inaccurate results, potentially leading to inappropriate therapy decisions and adverse health consequences.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Roche Diabetes Care, Inc.

Roche Diabetes Care, Inc. has 29 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report