Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0492-2013·Announced 2012-12-19

Roche DataCara GM Software Recalled for Diagnostic Issue

Roche Molecular Systems is recalling DataCara GM software due to a device-associated diagnostic issue. 479 units were distributed nationwide.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any specific injuries, illnesses, or hospitalizations, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Roche Molecular Systems, Inc. is recalling DataCara GM, an information management system used for managing blood glucose testing data. The recall involves 479 units that were distributed nationwide.

The recall was initiated because the company became aware of a device-associated diagnostic software issue. The source text does not specify the exact nature of the software defect or any reported injuries or illnesses.

Consumers and healthcare providers who possess this software should contact Roche Molecular Systems, Inc. for further instructions on how to address the issue.

The recalled product

Product: DataCara GM is an information management system that provides data management functionality for managing blood glucose testing data.
Manufacturer: Roche Molecular Systems, Inc.
Category: Medical Device — Diagnostic Software
Hazard: software-defect
Affected units: 479

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

Device-associated diagnostic software

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 10 recalled by Roche Molecular Systems, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 10 products in this recall →

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