Roche Recalls Anti-TPO Assay Kits Due to Updated Interference Claim
Roche Diagnostics is recalling 11,870 Elecsys Anti-TPO Assay kits because internal studies found the radio frequency interference claim no longer met for specific cobas e analyzers.
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 involves a labeling/claim update regarding RF interference without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Roche Diagnostics Operations, Inc. is recalling 11,870 reagent kits of the Elecsys Anti-TPO Assay, Catalog Number 06368590190. The recall affects all current and upcoming lots distributed nationwide in the United States.
The recall was initiated after recent internal verification studies determined that the current radio frequency (RF) interference claim for the assay is no longer met when used on cobas e 411, 601, and 602 analyzers. As a result, the manufacturer has updated the claim to reflect these findings.
This recall is classified as Class II by the FDA. Users of the affected kits should contact Roche Diagnostics for further instructions regarding the updated claim and any necessary actions.
The recalled product
- Product
- Elecsys Anti-TPO Assay on cobas e analyzers 411, 601, 602, Catalog Number 06368590190
- Manufacturer
- Roche Diagnostics Operations, Inc.
- Hazard
- Affected units
- 11,870
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)
- All current and upcoming lots
Distribution
Distributed nationwide across the United States.
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