Class II — Abbott Laboratories, Inc
| Recalling firm | ABBOTT LABORATORIES |
|---|---|
| Registered facility | View this company's 64 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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. |
| 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 … |
| Quantity | 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… |
| Initiated | 2017-12-08 |
| Classified | 2018-03-06 |
| Terminated | 2019-07-11 |
| Recall number | Z-0923-2018 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Abbott Laboratories, Inc (Z-0923-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/78838/
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