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Recall Observatory FDA recall evidence

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

June 11, 2015

Class II

Product summary

Firm
Abbott Laboratories
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

    reason.potency_specification_failure · v1.0.0

    does not meet specifications