FDA-Device2020-09-23Class II
Elecsys Anti-TPO Assay on cobas e analyzers 411, 601, 602, Catalog Number 06368590190
Roche Diagnostics Operations, Inc.
Hazard
Recent internal verification studies found the current RF interference claim to no longer be met for the assay on the cobas e 411, 601, and 602 analyzers. Therefore, the claim has been updated.
Sold states
US Nationwide
Affected count
11,870 reagent kits
Manufactured in
9115 Hague Rd, N/A, Indianapolis, IN, United States
Products
Elecsys Anti-TPO Assay on cobas e analyzers 411, 601, 602, Catalog Number 06368590190
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2981-2020Don't want to check this manually?
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