ARCHITECT c4000 part number 02P24; ARCHITECT c8000 part number 01G06; ARCHITECT c16000 part number 03L77 Clinical Chemistry systems.
This recall has been completed (originally issued September 29, 2017).
- Company
- Abbott Laboratories, Inc
- Recall Initiated
- September 29, 2017
- Recall Number
- Z-0165-2018
- Quantity
- 34 units
- Firm Location
- Irving, TX
- Official Source
- View on FDA website ↗
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
Worldwide distribution to US, Canada, France, and Germany.
Lot / 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
Root Cause
Component design/selection
Action Taken
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.