FDA-Device2017-11-29Class II
Tubing, Peristaltic Head Part Number 7-35009685-01 for use in 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
44 units
Manufactured in
1921 Hurd Dr, N/A, Irving, TX, United States
Products
Tubing, Peristaltic Head Part Number 7-35009685-01 for use in clinical chemistry systems.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0166-2018Don't want to check this manually?
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