# FDA recall Z-0922-2018

> **Abbott Laboratories, Inc** · Class II · device recall initiated 2017-12-08.

## Product

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.

## 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.

## 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, R

## Key facts

- **Recall number:** Z-0922-2018
- **Recalling firm:** Abbott Laboratories, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-12-08
- **Report date:** 2018-03-14
- **Termination date:** 2019-07-11

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Irving, TX, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0922-2018

## Citation

> AI Analytics. FDA recall Z-0922-2018. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/Z-0922-2018. Source: US FDA. Licensed CC0.

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