Exact FDA event identifier

Event 78225

2 recalled-product records grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: September 29, 2017
Product types: Device
Classifications: Class II
Statuses: Completed
Recalling firm wording: Abbott Laboratories, Inc

Dossier provenance

Source snapshots represented here

openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 2

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

Z-0165-2018

Recall number: Z-0165-2018
Initiated: September 29, 2017
Classification: Class II
Status: Completed
Recalling firm: Abbott Laboratories, Inc
Quantity: 34 units

App-derived interpretation

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

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.

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.

device · product 2 of 2

Tubing, Peristaltic Head Part Number 7-35009685-01 for use in clinical chemistry systems.

Z-0166-2018

Recall number: Z-0166-2018
Initiated: September 29, 2017
Classification: Class II
Status: Completed
Recalling firm: Abbott Laboratories, Inc
Quantity: 44 units

App-derived interpretation

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Serial numbers - 125589-1-2, 125589-1-4

Distribution pattern

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