FDA Device recall Z-1104-2019
Abbott ARCHITECT c16000 Processing Module, List No. 03L77 - Product Usage: The Abbott ARCHITECT System is intended for In Vitro diagnostic…
- FDA Device
- Class II
- terminated
- Published 2019-04-17
On 2019-04-17 the FDA classified a Class II recall of Abbott ARCHITECT c16000 Processing Module, List No. 03L77 - Product Usage: The Abbott ARCHITECT System is intended for In Vitro diagnostic… by Abbott Laboratories, citing there is a potential to generate incorrect results on the instrument if particular error codes are not resolved before transitioning to the Running status.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1104-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-07-17 |
| Published | 2019-04-17 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Abbott Laboratories |
| Distribution | US |
Product
Abbott ARCHITECT c16000 Processing Module, List No. 03L77 - Product Usage: The Abbott ARCHITECT System is intended for In Vitro diagnostic use only. The Abbott ARCHITECT Clinical Chemistry Systems are designed to perform automated chemistry tests, utilizing photometry and potentiometric technology. The ARCHITECT c4000, c8000, c16000 sample pipettor assemblies include a fluid sense/pressure monitoring system that helps identify errors in aspiration.
Reason
There is a potential to generate incorrect results on the instrument if particular error codes are not resolved before transitioning to the Running status.
Identifiers
| code_info | All serial numbers |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1104-2019%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.