FDA Device recall Z-2202-2015
ARCHITECT c8000 System List Number 01G06-98 Product Usage: The Abbott ARCHITECT cSystem is intended for In Vitro diagnostic use only
- FDA Device
- Class II
- terminated
- Published 2015-07-29
On 2015-07-29 the FDA classified a Class II recall of ARCHITECT c8000 System List Number 01G06-98 Product Usage: The Abbott ARCHITECT cSystem is intended for In Vitro diagnostic use only by Abbott Laboratories, citing the ARCHITECT c8000 instrument contains tubing that does not meet specifications and has the potential to leak.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2202-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-06-11 |
| Published | 2015-07-29 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Abbott Laboratories |
| Distribution | US |
Product
ARCHITECT c8000 System List Number 01G06-98 Product Usage: The Abbott ARCHITECT cSystem is intended for In Vitro diagnostic use only. It is designed to perform automated: chemistry tests, utilizing photometry and potentiometric technology.
Reason
The ARCHITECT c8000 instrument contains tubing that does not meet specifications and has the potential to leak.
Identifiers
| code_info | Serial Numbers: C802239, C802312, C802260, C802447, C801911 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2202-2015%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.