Z-1104-2019Class II

Abbott ARCHITECT c16000 Processing Module, List No. 03L77 -

Name: Z-1104-2019 Abbott ARCHITECT c16000 Processing Module, List No. 03L77 -
Creator: Abbott Laboratories, Inc
Published: 2018-07-17
License: https://open.fda.gov/license/

Abbott Medical / initiated 2018-07-17 / Terminated / root cause: software

FDA source

Abbott Laboratories, Inc began a recall of Abbott ARCHITECT c16000 Processing Module, List No. 03L77 - Product Usage: The Abbott ARCHITECT System is intended for In Vitro diagnostic use only. The Abbott... on 2018-07-17. FDA classified it as Class II and gives the reason as "There is a potential to generate incorrect results on the instrument if particular error codes are not resolved before transitioning to the Running status". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1104-2019
Classification: Class II
Status: Terminated
Initiated: 2018-07-17
Posted: 2019-04-08
Terminated: 2020-09-23
Recalling firm: Abbott Medical
Product: Abbott ARCHITECT c16000 Processing Module, List No. 03L77 - 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.
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
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.
Root cause tag: software
FDA root cause: Software design
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.
Quantity in commerce: 1,666 instruments
Distribution: 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.
Product codes and lots: All serial numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1104-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1102-2019	Class II	Terminated	Voluntary: Firm initiated	2019-04-17	2019-04-08
Z-1103-2019	Class II	Terminated	Voluntary: Firm initiated	2019-04-17	2019-04-08
Z-1104-2019	Class II	Terminated	Voluntary: Firm initiated	2019-04-17	2019-04-08

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)