CLASS II Device recall · Reported 17 Apr 2019 · FDA Enforcement Report

Abbott Architect c4000 Processing Module, List No. 02P24 recalled

Abbott Laboratories is recalling Abbott Architect c4000 Processing Module, List No. 02P24, distributed nationwide in the US. The recall was initiated on 17 Jul 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll serial numbers

Quantity recalled3,675 instruments

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1102-2019
FDA event ID: 82104
Recalling firm: Abbott Laboratories, Irving, TX
Classification: Class II
Status: Terminated
Recall initiated: 17 Jul 2018
FDA classified: 8 Apr 2019
Reported: 17 Apr 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Patient Monitors

Timeline

17 Jul 2018	Recall initiated by company
8 Apr 2019	Classified by FDA	+265 days
17 Apr 2019	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

There is a potential to generate incorrect results on the instrument if particular error codes are not resolved before transitioning to the Running status.

Product as listed by the FDA

Abbott ARCHITECT c4000 Processing Module, List No. 02P24 - Product Usage: The Abbott ARCHITECT System is intended for In Vitro diagnostic use only. The Abbott ARCHITECT Clinical Chemistry Systems are designed to perform automated chemistry tests, utilizing photometry and potentiometric technology. The ARCHITECT c4000, c8000, c16000 sample pipettor assemblies include a fluid sense/pressure monitoring system that helps identify errors in aspiration.

Where it was distributed

Worldwide distribution - US Nationwide and countries Afghanistan, Albania, Algeria, Angola, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahamas, Bangladesh, Belarus, Belgium, Bermuda, Bosnia and Herzegovina, Brazil, Brunei, Bulgaria, Burkina FASO, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Croatia, Curacao, Cyprus, Czech Republic, Democratic Rep. of Congo, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Ethiopia, Finland, France, Georgia, Germany, Ghana, Greece, Guatemala, Honduras, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Ivory Coast, Jamaica, Jordan, Kazakhstan, Kenya, Kuwait, Kyrgyzstan, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Macedonia, Malawi, Malaysia, Maldives, Mali, Mauritania, Mauritius, Mexico, Moldova, Montenegro, Montserrat, Morocco, Myanmar, Netherlands, New Zealand, Nigeria, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Rwanda, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, St. Lucia, St. Vincent, Sweden, Switzerland, Taiwan, Tajikistan, Tanzania, Thailand, Trinidad & Tobago, Tunisia, Turk & Caicos, Turkey, UAE, Uganda, UK, Ukraine, Uruguay, Venezuela, Vietnam, Yemen, Zambia, and Zimbabwe.

Nationwide Georgia

Questions about this recall

Is Abbott Architect c4000 Processing Module, List No. 02P24 recalled?

Yes. Abbott Laboratories recalled Abbott Architect c4000 Processing Module, List No. 02P24 on 17 Jul 2018. The recall is Class II and its status is Terminated. Recall number Z-1102-2019.

Why was it recalled?

There is a potential to generate incorrect results on the instrument if particular error codes are not resolved before transitioning to the Running status.

Which lots are affected?

All serial numbers

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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