Terminated

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.

FDA Recall Z-1102-2019 · Posted None

Recalling FirmAbbott Laboratories, Inc

Recall StatusTerminated

Product CodeJJE

Date Initiated2018-07-17

Date Terminated2020-09-23

Product Quantity3,675 instruments

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.

Firm Action

Recall letters were issued in the U.S. 7/17/2018 via FedEx overnight mail notifying the consignee of the issue, patient impact, and necessary actions to take. Globally, primary methods of issuance were via mail, telephone, and email.

Root Cause

Software design

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K980367AEROSET SYSTEMAbbott Laboratories · 1998-04-01

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.