Roche Recalls Anti-HAV IgM Assay Due to Software Error
Roche Diagnostics is recalling 712 units of the Elecsys Anti-HAV IgM assay because a software error caused incorrect test settings to be downloaded.
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 typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The source text describes a software configuration error without reporting any specific patient injuries or illnesses, aligning with a moderate severity level for a diagnostic device software defect.
Plain-English summary
Roche Diagnostics Operations, Inc. is recalling 712 units of the Elecsys Anti-HAV IgM assay, catalog number 07026773190. This in vitro diagnostic test is used to detect IgM antibodies to hepatitis A virus in human serum and plasma. The recall covers units distributed nationwide in the United States.
The recall was initiated because the current software version of the Anti-HAV IgM APP-file (version 06.05-101) downloaded an erroneous Border Area setting. The software used a setting of (1.0 1.00) instead of the correct setting of (0.90 1.10). This error affects the specific software file version identified in the recall notice.
Healthcare facilities and laboratories that have received these units should stop using the affected software version and contact Roche Diagnostics for further instructions. The recall is limited to the specific catalog number and software version listed.
The recalled product
- Product
- Elecsys Anti-HAV IgM assay-for the in vitro qualitative detection of IgM antibodies to hepatitis A virus (anti-HAV IgM) in human serum and plasma Catalog number: 07026773190
- Manufacturer
- Roche Diagnostics Operations, Inc.
- Affected units
- 712
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)
- Anti-HAV IgM APP-file (version 06.05-101)
Distribution
Distributed nationwide across the United States.
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