Z-0165-2018 Class II

Recalled by Abbott Laboratories, Inc — Irving, TX

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