# FDA recall Z-2174-2024

> **Roche Diabetes Care, Inc.** · Class II · device recall initiated 2024-05-13.

## Product

Accu-Chek Guide (SC) Kit -Intended to quantitatively measure glucose in fresh capillary whole blood from the fingertip, palm, and upper arm as an aid in monitoring the effectiveness of glucose control.  Product REF Number: 08453071001

## Reason for recall

The reason for recall is the meters may show an incorrect measurement unit (mmol/L rather than mg/dL) and may result in the wrong unit of measure.  Which may subsequently cause an error in interpreting a result as approximately 18 times lower that the actual blood glucose. Potential immediate health consequences of the glucose meter providing a reading in the wrong units of measurement (UOM) may result in inappropriate rescue therapy for presumed hypoglycemia including urgent and repeat administration of carbohydrates.  This in turn could lead to frequent episodes of hyperglycemia which is unrecognized and undertreated.Long range consequences of continued use of the affected meters could include mismanagement of the patient s diabetes for longer periods of time potentially resulting in a major health event (in general persistent and/or severe hyperglycemia) that may lead them to seek medical attention, and depending on the duration of hyperglycemia, could contribute to the development 

## Distribution

Nationwide and Worldwide

## Key facts

- **Recall number:** Z-2174-2024
- **Recalling firm:** Roche Diabetes Care, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-05-13
- **Report date:** 2024-07-03

- **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-2174-2024

## Citation

> AI Analytics. FDA recall Z-2174-2024. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/Z-2174-2024. Source: US FDA. Licensed CC0.

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