Z-0923-2018Class II

ARCHITECT c16000 Cuvette Segment, Part #09D32-05/ 03L77, a component to the ARCHITECT Clinical Chemistry...

Name: Z-0923-2018 ARCHITECT c16000 Cuvette Segment, Part #09D32-05/ 03L77, a component to the ARCHITECT Clinical Chemistry...
Creator: Abbott Laboratories, Inc
Published: 2017-12-08
License: https://open.fda.gov/license/

Abbott Medical / initiated 2017-12-08 / Terminated / root cause: design

FDA source

Abbott Laboratories, Inc began a recall of ARCHITECT c16000 Cuvette Segment, Part #09D32-05/ 03L77, a component to the ARCHITECT Clinical Chemistry system. There are 15 segments with each cuvette... on 2017-12-08. 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, c8000, and c16000 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-0923-2018
Classification: Class II
Status: Terminated
Initiated: 2017-12-08
Posted: 2018-01-18
Terminated: 2019-07-11
Recalling firm: Abbott Medical
Product: ARCHITECT c16000 Cuvette Segment, Part #09D32-05/ 03L77, a component to the ARCHITECT Clinical Chemistry system. There are 15 segments with each cuvette segment holding 11 cuvette pairs (22 cuvettes) for a total of 165 cuvettes pairs or a total of 330 cuvettes (22 cuvettes x 15 cuvette segments) per reaction carousel. The firm name on the label is Abbott Laboratories, Abbott Park, IL. The Abbott ARCHITECT Clinical Chemistry Systems are designed to perform automated chemistry tests utilizing photometry and potentiometric technology. The cuvette segments are a component of the system and are racks that sit in the reaction carousel and hold cuvettes.
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, c8000, and c16000 instrument.
Root cause tag: design
FDA root cause: Device Design
Action: The firm, Abbott Laboratories, issued a "Product Correction" letter dated 12/8/2017 via overnight mail on 12/8/2017 to its customers. The letter describes the product, problem and actions to be taken. The customers were instructed to adhere to the new instructions listed in Appendix A to avoid damaging the cuvette segments; If a cuvette segment with a detached bottom is identified, replace it before performing any additional testing on your ARCHITECT Clinical Chemistry System; 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 this letter and retain this letter for your laboratory records. The procedures will be updated in a future version of the ARCHITECT Operations Manual. 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: 1,560 ARCHITECT c16000 Systems
Distribution: Worldwide Distribution: US (nationwide) including Puerto Rico and countries of: Afghanistan, Albania, Algeria, Angola, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahamas, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Brunei, Bulgaria, Burkina Faso, Cameroon, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Croatia, Curacao, Cyrus, Czech Republic, Dem Rep of The Congo, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Ethiopia, Finland, France, Gaza & Jericho, Georgia, Germany, 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, Mexico, Moldova, Montenegro, Montserrat, Morocco, Netherlands, New Zealand, Nigeria, North Yemen, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia (CIS), Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, St. Lucia, St. Vincent, Sweden, Switzerland, Taiwan, Tajikistan, Tanzania, Thailand, Trinidad & Tobago, Tunisia, Turkey, UAE, Uganda, United Kingdom, Uruguay, Venezuela, Vietnam, Zambia and Zimbabwe. .
Product codes and lots: All serial numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0923-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0921-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-14	2018-03-06
Z-0922-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-14	2018-03-06
Z-0923-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-14	2018-03-06

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)