Device product
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.
Z-2202-2015
Product summary
- Event
- Event 71473
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5 units
- Official record key
device-enforcement:Z-2202-2015
Official wording
Reason: The ARCHITECT c8000 instrument contains tubing that does not meet specifications and has the potential to leak.
Code information: Serial Numbers: C802239, C802312, C802260, C802447, C801911
Distribution pattern: US Nationwide Distribution in the states of CA, AL, NY and WI.
Derived failure modes
-
Potency or specification failure
does not meet specifications