Reported Jul 29, 2015 · Terminated

ARCHITECT c8000 System List Number 01G06-98 Product Usage: The Abbott ARCHITECT cSystem is intended for In Vitro…

Abbott Laboratories

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Abbott Laboratories · 100 Abbott Park Rd · Abbott Park, IL · 60064-3502

Is this the product you have?

  • ARCHITECT c8000 System
  • List Number 01G06-98 Product UsageThe Abbott ARCHITECT cSystem is intended for In Vitro diagnostic use only
  • It is designed to perform automatedchemistry tests, utilizing photometry and potentiometric technology
Lot codes and dates
  • Serial Numbers
    • C802239
    • C802312
    • C802260
    • C802447
    • C801911
Amount recalled
5 units

Where it was sold

Why it was recalled

The ARCHITECT c8000 instrument contains tubing that does not meet specifications and has the potential to leak.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Feb 9, 2016 · Data as of Sep 19, 4:45 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.