# FDA recall Z-2185-2018

> **Roche Diabetes Care, Inc.** · Class II · device recall initiated 2018-05-07.

## Product

Accu-Chek Aviva Plus Test Strip, Blood glucose monitoring system, Catalog nos. 06908217001, 06908268001, 06908349001,06908217001    Product Usage:  The Accu-Chek Aviva Plus test strips are for use with the Accu-Chek Aviva Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, or palm.

## Reason for recall

The recalling firm identified four US lots of test strips out of specification. Affected strips show increased potential for strip errors prior to applying blood, strips not detected once inserted, or biased results, which may not be detectable. In the case of a biased result, incorrect action could be taken by the user in response to the displayed blood glucose result.

## Distribution

Worldwide Distribution - US Nationwide distribution. Foreign distribution to Argentina  Armenia  Australia  Austria  Azerbaijan  Bahamas  Bahrain  Barbados  Belgium  Brazil  Bulgaria  Canada  Chile  China  Colombia  Costa Rica  Denmark  Dominican Republic  El Salvador  Finland  Georgia  Germany  Ghana  Greece  Guatemala  Honduras  Hong Kong (SAR China)  Hungary  India  Indonesia  Israel  Italy  Jamaica  Japan  Jordan  Ireland  Kenya Korea Kuwait Lebanon Lithuania Luxembourg Malaysia Malta Mexico Myanmar Netherlands New Zealand Norway Oman Pakistan Philippines Poland Russian Federation New Zealand Saudi Arabia Serbia Singapore Slovenia South Africa Spain Sweden Switzerland Taiwan (Republic of China), Thailand, United Arab Emirates, United Kingdom, Vietnam, Portugal"

## Key facts

- **Recall number:** Z-2185-2018
- **Recalling firm:** Roche Diabetes Care, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-05-07
- **Report date:** 2018-06-20
- **Termination date:** 2020-01-16

- **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-2185-2018

## Citation

> AI Analytics. FDA recall Z-2185-2018. Retrieved 2026-05-27 from https://api.ai-analytics.org/recall/Z-2185-2018. Source: US FDA. Licensed CC0.

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