Device product
Tubing, Peristaltic Head Part Number 7-35009685-01 for use in clinical chemistry systems.
Z-0166-2018
Product summary
- Event
- Event 78225
- Status
- Completed
- Classification
- Class II
- Quantity
- 44 units
- Official record key
device-enforcement:Z-0166-2018
Official wording
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.
Code information: Serial numbers - 125589-1-2, 125589-1-4
Distribution pattern: Worldwide distribution to US, Canada, France, and Germany.
Derived failure modes
-
Unknown
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.