FDA Recall
Completed
ARCHITECT c4000 part number 02P24; ARCHITECT c8000 part number 01G06; ARCHITECT c16000 part number 03L77 Clinical Chemistry systems.
Recall: Z-0165-2018
·
Initiated September 29, 2017
Recall
- Recall Number
- Z-0165-2018
- Event Number
- 78225
- Firm
- Abbott Laboratories, Inc
- FEI Number
- 1628664
- Product Code
- JJE
- Status
- Completed
- Root Cause
- Component design/selection
- Initiated
- September 29, 2017
- Address
- 1921 Hurd Dr, Irving, TX, 75038-4313
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.
Action
All worldwide ARCHITECT Clinical Chemistry System customers with impacted instruments will receive the Product Correction Letter dated, 9/29/17. A customer reply is requested from all affected consignees.
Distribution
Worldwide distribution to US, Canada, France, and Germany.
Quantity
34 units