Class 2 Device Recall ARCHITECT c4000 Cuvette Segment

• Date Initiated by Firm: January 15, 2015
• Create Date: October 06, 2017
• Recall Status: Terminated on July 20, 2020
• Recall Number: Z-0011-2018
• Recall Event ID: 77828
• 510(K)Number: K980367
• Product Classification: Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
• Product: ARCHITECT c4000 Cuvette Segment, List number 02P75-01. The firm name on the label is Abbott Laboratories, Abbott Park, IL. Cuvette segments are a component to the ARCHITECT c4000 system. Cuvette segments are racks that sit in the reaction carousel and hold cuvettes. Each cuvette segment holds 11 cuvettes. With 9 segments, the reaction carousel holds 99 cuvettes. The Abbott ARCHITECT System is intended for In Vitro diagnostic use only. The system is designed to perform automated chemistry tests, utilizing photometry and potentiometric technology.
• Code Information: All c4000s
• Recalling Firm/ Manufacturer: Abbott Laboratories, Inc; 1921 Hurd Dr; Irving TX 75038-4313
• For Additional Information Contact: Albert Chianello; 224-668-1923
• Manufacturer Reason for Recall: There is a potential to generate falsely-depressed patient results in the cuvettes adjacent to the detached segment post for any assay run on the c4000 instrument.
• FDA Determined Cause: Device Design
• Action: The firm, Abbott Laboratories, sent a "Product Correction" letter dated June 26, 2017 to is customers via overnight mail who had not had the Field Action Mandatory Technical Service Bulletin completed on their instrument. The letter described the product, problem and actions to be taken. The customers were instructed to do the following: -Contact their representative to schedule an inspection of their cuvette segments. -If a detached segment is identified o A replacement segment will be provided at no charge. o Follow your laboratory protocol regarding previously reported patient results from cuvettes within the impacted segment. -If you have forwarded the product listed above to other laboratories, please inform them of this Product Correction and provide to them a copy of the letter. -Retain the letter for your laboratory records. -Complete and return the Customer Reply Form, prior to July 11, 2017 via FAX# 1-800-777-0051 or email QAGCO@abbott.com. Even if you no longer have the instrument(s). Note: consignees who have the instruments that have not had the FA Mandatory TSB completed are the ones who are targeted for this current field action. If you or any of the health care providers you serve have any questions regarding this information, U.S. Customers please contact Customer Service at 18774ABBOTT (available 24 hours a day, 7 days a week). Customers outside the U.S., please contact your local area Customer Service.
• Quantity in Commerce: 1,385 cuvette segments
• Distribution: Worldwide Distribution: US (nationwide) including Puerto Rico, and countries of: Algeria, Angola, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahamas, Bangladesh, Belarus, Belgium, Bosnia & Herzegovina, Brazil, Brunei, Bulgaria Burkina Faso, Canada, Chile, China, Columbia, Costa Rica, Croatia, Czech Republic, Ecuador, Egypt, El Salvador, Estonia, Ethiopia, Finland, France, Gaza & Jericho, Georgia, Germany, Ghana, Greece, Guatemala, Honduras, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Ivory Coast, Jordan, Kazakhstan, Kenya, Kuwait, Kyrgyzstan, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malawi, Malaysia, Maldives, Mali, Mauritania, Mexico, Morocco, Netherlands, New Zealand, Nigeria, North Yemen, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia (CIS), Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, St. Lucia, Sweden, Switzerland, Tajikistan, Tanzania, Thailand, Trinidad & Tobago, Tunisia, Turkey, Turks & Caicos, UAE, Uganda, United Kingdom, Uruguay, Venezuela, Viet Nam, Zambia, and Zimbabwe.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = JJE