Roche Elecsys 2010 Analyzer Software Malfunction Recall
Roche Diagnostics is recalling 255 Elecsys 2010 analyzers due to a software malfunction that may cause data mismatches in sample and control files.
What this means for you
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 hazard is a software malfunction leading to data mismatch without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Roche Diagnostics Corporation is recalling 255 units of the Roche / Hitachi MODULAR Analyzer Systems, specifically the Elecsys 2010 analyzer (disk and rack systems). The affected models include catalog numbers 11568248001, 11568248692, 11804014001, and 11804014692. These instruments were distributed nationwide.
The recall is being conducted because a software malfunction can occur in the Sample & Control data file on the cobas e 411 and Elecsys 2010 analyzers. This malfunction may lead to a potential data mismatch. The Elecsys 2010 is a fully automated, random access, computer-controlled analytical system used for quantitative and qualitative determinations of analytes in body fluids.
Healthcare facilities and laboratories that possess these specific instruments should contact Roche Diagnostics Corporation for further instructions on how to resolve the software issue.
The recalled product
- Product
- Roche / Hitachi MODULAR Analyzer Systems-Immunoassay Analyzer-Model/Catalog/Part Number: 11568248001/11568248692 - Elecsys 2010 analyzer (disk system) and 11804014001/11804014692 - Elecsys 2010 analyzer (rack system) Medical Device Listing number: D053244 - Elecsys 2010 Elecs
- Manufacturer
- Roche Diagnostics Corporation
- Affected units
- 255
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)
- none
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Roche Diagnostics Corporation 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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