Z-0011-2018Class II

ARCHITECT c4000 Cuvette Segment, List number 02P75-01. The firm name on the label is Abbott Laboratories...

Name: Z-0011-2018 ARCHITECT c4000 Cuvette Segment, List number 02P75-01. The firm name on the label is Abbott Laboratories...
Creator: Abbott Laboratories, Inc
Published: 2015-01-15
License: https://open.fda.gov/license/

Abbott Medical / initiated 2015-01-15 / Terminated / root cause: design

FDA source

Abbott Laboratories, Inc began a recall of 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... on 2015-01-15. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0011-2018
Classification: Class II
Status: Terminated
Initiated: 2015-01-15
Posted: 2017-10-06
Terminated: 2020-07-20
Recalling firm: Abbott Medical
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.
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
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.
Root cause tag: design
FDA root 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 [email protected]. 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.
Product codes and lots: All c4000s

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0011-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0011-2018	Class II	Terminated	Voluntary: Firm initiated	2017-10-18	2017-10-06

Product code JJE

K980367Class IIAeroset SystemAbbott Laboratories / cleared 1998-04-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)