FDA Device recall Z-0011-2018
ARCHITECT c4000 Cuvette Segment, List number 02P75-01
- FDA Device
- Class II
- terminated
- Published 2017-10-18
On 2017-10-18 the FDA classified a Class II recall of ARCHITECT c4000 Cuvette Segment, List number 02P75-01 by Abbott Laboratories, citing 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 instrument.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0011-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-01-15 |
| Published | 2017-10-18 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Abbott Laboratories |
| Distribution | US |
Product
ARCHITECT c4000 Cuvette Segment, List number 02P75-01. The firm name on the label is Abbott Laboratories, Abbott Park, IL. Cuvette segments are a component to the ARCHITECT c4000 system. Cuvette segments are racks that sit in the reaction carousel and hold cuvettes. Each cuvette segment holds 11 cuvettes. With 9 segments, the reaction carousel holds 99 cuvettes. The Abbott ARCHITECT System is intended for In Vitro diagnostic use only. The system is designed to perform automated chemistry tests, utilizing photometry and potentiometric technology.
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 instrument.
Identifiers
| code_info | All c4000s |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0011-2018%22
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