FDA-Device2017-11-29Class II
ARCHITECT c4000 part number 02P24; ARCHITECT c8000 part number 01G06; ARCHITECT c16000 part number 03L77 Clinical Chemistry systems.
Hazard
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.
Sold states
Worldwide distribution to US, Canada, France, and Germany.
Affected count
34 units
Manufactured in
1921 Hurd Dr, N/A, Irving, TX, United States
Products
ARCHITECT c4000 part number 02P24; ARCHITECT c8000 part number 01G06; ARCHITECT c16000 part number 03L77 Clinical Chemistry systems.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0165-2018Don't want to check this manually?
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