FDA Enforcement
Class II
Completed
Tubing, Peristaltic Head Part Number 7-35009685-01 for use in clinical chemistry systems.
Recall: Z-0166-2018
·
Reported November 29, 2017
Enforcement
- Recall Number
- Z-0166-2018
- Event ID
- 78225
- Classification
- Class II
- Status
- Completed
- Product Type
- Devices
- Firm
- Abbott Laboratories, Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- November 29, 2017
- Initiation Date
- September 29, 2017
- Classification Date
- November 21, 2017
- Address
- 1921 Hurd Dr, N/A, Irving, TX, 75038-4313, United States
Description
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.
Code Info
Serial numbers - 125589-1-2, 125589-1-4
Distribution
Worldwide distribution to US, Canada, France, and Germany.
Quantity
44 units