Z-0166-2018 Class II
Recall Details
- Product Type
- Devices
- Report Date
- November 29, 2017
- Initiation Date
- September 29, 2017
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 44 units
Product Description
Tubing, Peristaltic Head Part Number 7-35009685-01 for use in clinical chemistry systems.
Reason for Recall
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.
Distribution Pattern
Worldwide distribution to US, Canada, France, and Germany.
Code Information
Serial numbers - 125589-1-2, 125589-1-4