# FDA recall Z-2352-2021

> **Roche Diabetes Care, Inc.** · Class II · device recall initiated 2021-07-28.

## Product

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

## Reason for recall

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.

## Distribution

Worldwide distribution - US Nationwide distribution.

## Key facts

- **Recall number:** Z-2352-2021
- **Recalling firm:** Roche Diabetes Care, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-07-28
- **Report date:** 2021-09-01

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Indianapolis, IN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2352-2021

## Citation

> AI Analytics. FDA recall Z-2352-2021. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-2352-2021. Source: US FDA. Licensed CC0.

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