Abbott Laboratories, Inc: Medical Device Recall in 2017 - (Recall #: Z-0165-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

ARCHITECT c4000 part number 02P24; ARCHITECT c8000 part number 01G06; ARCHITECT c16000 part number 03L77 Clinical Chemistry systems.

Product Classification:

Class II

Date Initiated: September 29, 2017

Date Posted: November 29, 2017

Recall Number: Z-0165-2018

Event ID: 78225

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.

Status: Completed

Product Quantity: 34 units

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

Distribution Pattern:

Worldwide distribution to US, Canada, France, and Germany.

Voluntary or Mandated:

Voluntary: Firm initiated