FDA recall Z-2981-2020

Product

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

Reason for recall

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.

Distribution

US Nationwide

Key facts

Status

Terminated

Initiation date

2020-08-20

Report date

2020-09-23

Termination date

2021-10-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

Indianapolis, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2981-2020