Lower riskMedical device recall · FDA · Published July 17, 2018
Abbott ARCHITECT c4000 Processing Module Recall: Incorrect Test Results Risk
Abbott recalls ARCHITECT c4000 Processing Module (List No. 02P24) due to potential incorrect test results if error codes aren't resolved before running tests. Affected units may need correction to ensure accurate diagnostic results.
There is a potential to generate incorrect results on the instrument if particular error codes are not resolved before transitioning to the Running status.
Take action
Contact the company
📍Recalling firmAbbott Laboratories, Inc1921 Hurd Dr · Irving, TX 75038-4313
✎ GovInfoNow plain-language explainer
Abbott is recalling its ARCHITECT c4000 Processing Module (List No. 02P24) because it can produce incorrect test results if error codes aren't properly resolved before starting tests. This affects laboratory equipment used for in vitro diagnostics, where accurate results are critical for patient care. Read more at govinfonow.com/recall/70486-abbott-architect-c4000-processing-module-recall-incorrect-test-results-risk.
“Abbott ARCHITECT c4000 Processing Module Recall: Incorrect Test Results Risk.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/70486-abbott-architect-c4000-processing-module-recall-incorrect-test-results-risk. Based on FDA recall #Z-1102-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1102-2019%22&limit=1).
The FDA announced on 2018-07-17 that Abbott Laboratories, Inc. is recalling its ARCHITECT c4000 Processing Module due to a potential for generating incorrect test results. This voluntary Class II recall affects 3,675 instruments distributed worldwide.
How to tell if you have it
Brand: Abbott
Product: ARCHITECT c4000 Processing Module
List No.: 02P24
Units affected: 3,675
The hazard
According to the FDA, there is a potential to generate incorrect results on the instrument if particular error codes are not resolved before transitioning to the Running status.
Context
GovInfoNow's records show Abbott Laboratories, Inc. has 11 other recalls on record since 2017-09-29. Other recent recalls of similar products include Abbott Alinity s System Software Version 2.8.0 Recall (2022-02-03), Abbott Alinity s System Recall (2021-07-12), and Abbott ARCHITECT C System Mixer Recall (2019-05-01). Other recent recalls of similar products include Abbott Medical Merlin PCS 365 (2026-05-12), Abbott ID NOW Influenza A & B 2 Kit (2026-02-09), and Roche cobas pro integrated solutions recall (2026-01-20).
How to tell if you have this one
Check for the product name 'Abbott ARCHITECT c4000 Processing Module' with List No. 02P24. All units are affected, but the specific serial numbers aren't listed in the recall notice.
Brand
Abbott
Category
Medical device
FDA recall event · 3 products
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Terminated
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.
Recall number
Product, codes & lots
Quantity
Z-1102-2019
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.; All serial numbers
3,675 instruments
Z-1103-2019
Abbott ARCHITECT c8000 Processing Module, List No. 01G06 - 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.; All serial numbers
3,794 instruments
Z-1104-2019
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.; All serial numbers
1,666 instruments
Based on the official FDA remedy
What to do — step by step
Check Error Codes
Ensure error codes are resolved before starting tests to prevent incorrect results.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA 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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 2.2 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1102-2019 (July 17, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1102-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.