FDA-Device2020-09-23Class II
Elecsys Anti-TPO Assay on cobas e analyzers 411, 601, 602, Catalog Number 06368590190
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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