FDA recall Z-0165-2018

Product

ARCHITECT c4000 part number 02P24; ARCHITECT c8000 part number 01G06; ARCHITECT c16000 part number 03L77 Clinical Chemistry systems.

Reason for recall

The Peristaltic Head tubing placed on the ARCHITECT c4000, c8000, and c16000 has the possibility to leak due to a manufacturing issue associated with the tubing connector.

Distribution

Worldwide distribution to US, Canada, France, and Germany.

Key facts

Status

Completed

Initiation date

2017-09-29

Report date

2017-11-29

Voluntary/Mandated

Voluntary: Firm initiated

Location

Irving, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0165-2018