medical Class II Updated 2020-09-23

Roche Diagnostics Operations, Inc. recalls Elecsys Anti-TPO Assay on cobas e analyzers 411, 601, 602, C

Recalled Product

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


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: All current and upcoming lots
View official government recall

Looking for safe alternatives?

Browse certified-safe products in this category on Amazon →