FDA-Device2015-07-29Class II
ARCHITECT c8000 System List Number 01G06-98 Product Usage: The Abbott ARCHITECT cSystem is intended for In Vitro diagnostic use only. It is designed to perform automated: chemistry tests, utilizing photometry and potentiometric technology.
Abbott Laboratories
Hazard
The ARCHITECT c8000 instrument contains tubing that does not meet specifications and has the potential to leak.
Sold states
US Nationwide Distribution in the states of CA, AL, NY and WI.
Affected count
5 units
Manufactured in
100 Abbott Park Rd, N/A, Abbott Park, IL, United States
Products
ARCHITECT c8000 System List Number 01G06-98 Product Usage: The Abbott ARCHITECT cSystem is intended for In Vitro diagnostic use only. It is designed to perform automated: chemistry tests, utilizing photometry and potentiometric technology.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2202-2015Don't want to check this manually?
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