# FDA recall Z-2187-2018

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

## Product

Accu-Chek Inform II Test Strip, Whole blood glucose test system, Catalog no. 05942861001    Product Usage:  The Accu-Chek Inform II test strips are for use with the Accu-Chek Inform II meter to quantitatively measure glucose (sugar) in venous whole blood, arterial whole blood, neonatal heel stick, or fresh capillary whole blood samples drawn from the fingertips as an aid in monitoring the effectiveness of glucose control. The system is not for use in diagnosis or screening of diabetes mellitus, nor for testing neonate cord blood samples.

## Reason for recall

The recalling firm has identified two lots of test strips that are out of specification. Affected test strips show an increased potential for: strip errors prior to applying a blood sample; strips not detected once inserted; or a biased result may occur, 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 as compared to the actual  blood glucose value.

## 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-2187-2018
- **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-2187-2018

## Citation

> AI Analytics. FDA recall Z-2187-2018. Retrieved 2026-05-27 from https://api.ai-analytics.org/recall/Z-2187-2018. Source: US FDA. Licensed CC0.

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