FDA-Device2017-11-29Class II
ARCHITECT c4000 part number 02P24; ARCHITECT c8000 part number 01G06; ARCHITECT c16000 part number 03L77 Clinical Chemistry systems.
Abbott Laboratories, Inc
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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