Z-0165-2018 Class II
FDA device recall Z-0165-2018 was initiated by Abbott Laboratories, Inc on September 29, 2017 and is designated Class II. 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. Affected quantity: 34 units.
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
- 34 units
Product Description
ARCHITECT c4000 part number 02P24; ARCHITECT c8000 part number 01G06; ARCHITECT c16000 part number 03L77 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
c400073, c400103, c400498, c400600, c400890, c400934, c400935, c401018, c401055, c401056, c401182, c401505, c401520, c401686, c401887, c460196, c460200, c460943, c461550, c803669, c803753, c1600144, c1600249, c1600251, c1600641, c1600720, c1600819, c1600859, c1600976, c1601350, c1601351