Abbott ARCHITECT c8000 Cuvette Segment Recall: Falsely Depressed Test Results Risk
Abbott recalls ARCHITECT c8000 Cuvette Segments (Part #01G46-01/01G06) that may cause falsely low test results. Affected units include 165 cuvettes per reaction carousel. Consumers should contact Abbott for details.
Lower-risk 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.
Contact the company
What happened, in plain English
Abbott is recalling c8000 Cuvette Segments that could cause test results to appear too low. This affects laboratory equipment used for clinical chemistry tests. If you have this component, it may lead to inaccurate patient results if used in the ARCHITECT system. Read more at govinfonow.com/recall/72356-abbott-architect-c8000-cuvette-segment-recall-falsely-depressed-test-results.
Source Summary by GovInfoNow · govinfonow.com/recall/72356-abbott-architect-c8000-cuvette-segment-recall-falsely-depressed-test-results · Updated August 31, 2026 · FDA enforcement record: FDA #Z-0922-2018
Cite this page
“Abbott ARCHITECT c8000 Cuvette Segment Recall: Falsely Depressed Test Results Risk.” GovInfoNow, updated August 31, 2026. https://govinfonow.com/recall/72356-abbott-architect-c8000-cuvette-segment-recall-falsely-depressed-test-results. Based on FDA recall #Z-0922-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0922-2018%22&limit=1).
Why it’s dangerous
The cuvette segments may detach during use, causing adjacent test cuvettes to produce falsely low results. This could lead to incorrect patient diagnoses if the system is used without proper maintenance.
Who’s affected
Laboratories using Abbott's ARCHITECT Clinical Chemistry systems may be affected. Those handling the recalled cuvette segments could face inaccurate test results.
How to tell if you have this one
Check for part numbers 01G46-01 or 01G06 on the cuvette segments. The segments hold 15 cuvettes each and are part of the ARCHITECT Clinical Chemistry system.
- Brand
Abbott- Category
Medical device
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) 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. .
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-0921-2018 | ARCHITECT c4000 Cuvette Segment, Part #02P75-01/02P24, a component to the ARCHITECT Clinical Chemistry system. There are 9 segments with each cuvette segment holding 11 cuvettes for a total of 99 cuvettes 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.; All serial numbers | 3,634 ARCHITECT c4000 systems |
| Z-0922-2018 | ARCHITECT c8000 Cuvette Segment, Part #01G46-01/01G06, a component to the ARCHITECT Clinical Chemistry system. There are 11 segments with each cuvette segment holding 15 cuvettes for a total of 165 cuvettes 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.; All serial numbers | 3,357 ARCHITECT c8000 Systems |
| Z-0923-2018 | 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.; All serial numbers | 1,560 ARCHITECT c16000 Systems |
What to do — step by step
Contact Abbott
Reach out to Abbott Laboratories for specific instructions on handling the recalled segments.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA 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,…” 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 19 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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-0922-2018 (December 8, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0922-2018 to see it in context.
- Plain-language summary written by qwen3:4b on August 31, 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.