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Recall Observatory FDA recall evidence

Device product

Elecsys Anti-TPO Assay on cobas e analyzers 411, 601, 602, Catalog Number 06368590190

Z-2981-2020

August 20, 2020

Class II

Product summary

Firm
Roche Diagnostics Operations, Inc.
Event
Event 86319
Status
Terminated
Classification
Class II
Quantity
11,870 reagent kits
Official record key
device-enforcement:Z-2981-2020

Official wording

Reason: 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.

Code information: All current and upcoming lots

Distribution pattern: US Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.