FDA recall Z-1270-2018

Product

cobas e 411 Immunoassay Analyzer (Discrete Photometric Analyzer for Clinical use), Catalog Numbers: 04775201001 (rack system), 04775279001 (disk system), 04775201973 (rack system) & 04775279973 (disk system).

Reason for recall

Complaints have been received concerning questionable results on analyzers due to customers utilizing 13 mm sample tubes without tube adapters.

Distribution

US Nationwide

Key facts

Status

Terminated

Initiation date

2017-12-18

Report date

2018-04-04

Termination date

2019-04-09

Voluntary/Mandated

Voluntary: Firm initiated

Location

Indianapolis, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1270-2018