Roche DataInnovations Instrument Manager Software Recalled for Diagnostic Issue
Roche Molecular Systems is recalling DataInnovations Instrument Manager software due to a device-associated diagnostic software issue.
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, which is typically associated with a temporary or medically reversible adverse health consequence. Since the source text does not report any specific injuries, illnesses, or deaths, and the hazard is a general software issue without explicit high-risk pathogen or structural defect details, it fits the Moderate category for a precautionary or low-risk software recall.
Plain-English summary
Roche Molecular Systems, Inc. is recalling DataInnovations (Instrument Manager) version 8.04. This software functions as middleware that interfaces between larger Clinical Chemistry and Immunology instrument systems and Laboratory Information Systems (LIS).
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 defect or the potential impact on diagnostic results.
Approximately 1,015 units of this software were distributed nationwide. The source text does not provide specific instructions for consumers or healthcare providers on how to resolve the issue or what immediate actions to take.
The recalled product
- Product
- DataInnovations (Instrument Manager) (version 8.04) interfaces middleware between larger Clinical Chemistry / Immunology instrument systems and LIS systems.
- Manufacturer
- Roche Molecular Systems, Inc.
- Hazard
- Affected units
- 1,015
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.
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