FDA recall Z-1268-2018

Product

c6000, Chemistry (Photometric, Discrete), for clinical use. - cobas e 601 module: Immunoassay Analyzer, Catalog Numbers: 04745922001, 05036348001, 05860652001, 04745922692, 05036348001 & 05036348692

Reason for recall

Complaints have been received concerning questionable results on analyzers due to customers utilizing 13 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-1268-2018