FDA Enforcement
Class II
Completed
ARCHITECT c4000 part number 02P24; ARCHITECT c8000 part number 01G06; ARCHITECT c16000 part number 03L77 Clinical Chemistry systems.
Recall: Z-0165-2018
·
Reported November 29, 2017
Enforcement
- Recall Number
- Z-0165-2018
- 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
ARCHITECT c4000 part number 02P24; ARCHITECT c8000 part number 01G06; ARCHITECT c16000 part number 03L77 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
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
Distribution
Worldwide distribution to US, Canada, France, and Germany.
Quantity
34 units