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Recall Observatory FDA recall evidence

Device product

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

Z-0165-2018

September 29, 2017

Class II

Product summary

Firm
Abbott Laboratories, Inc
Event
Event 78225
Status
Completed
Classification
Class II
Quantity
34 units
Official record key
device-enforcement:Z-0165-2018

Official wording

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 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.