FDA Device recall Z-0166-2018
Tubing, Peristaltic Head Part Number 7-35009685-01 for use in clinical chemistry systems
- FDA Device
- Class II
- completed
- Published 2017-11-29
On 2017-11-29 the FDA classified a Class II recall of Tubing, Peristaltic Head Part Number 7-35009685-01 for use in clinical chemistry systems by Abbott Laboratories, citing the Peristaltic Head tubing placed on the ARCHITECT c4000, c8000, and c16000 has the possibility to leak due to a manufacturing issue associated with the tubing connector.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0166-2018 |
| Classification | Class II |
| Status | completed |
| Initiated | 2017-09-29 |
| Published | 2017-11-29 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Abbott Laboratories |
| Distribution | n/a |
Product
Tubing, Peristaltic Head Part Number 7-35009685-01 for use in clinical chemistry systems.
Reason
The Peristaltic Head tubing placed on the ARCHITECT c4000, c8000, and c16000 has the possibility to leak due to a manufacturing issue associated with the tubing connector.
Identifiers
| code_info | Serial numbers - 125589-1-2, 125589-1-4 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: completed.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0166-2018%22
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