Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 72154

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
September 09, 2015
Product types
Device
Classifications
Class II
Statuses
Terminated
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

1 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 1

ARCHITECT i2000SR System The Abbott ARCHITECT System is intended for In Vitro diagnostic use only. The ARCHITECT system is designed to perform automated immunoassay tests, utilizing CMIA (chemiluminescent microparticle assay) detection technology.

Z-0163-2016
Recall number
Z-0163-2016
Initiated
September 09, 2015
Classification
Class II
Status
Terminated
Recalling firm
Abbott Laboratories, Inc
Quantity
65 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Incorrect tubing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Incorrect tubing.

Code information

ISR03967, ISR04737, ISR01461, ISR01998, ISR01964, ISR02446, ISR02751, ISR02781, ISR05266, ISR04520, ISR01460, ISR01442, ISR01988, ISR03034, ISR01194, ISR01583, ISR01955, ISR02437, ISR03144, ISR03352, ISR04369, ISR02360, ISR02361, ISR02842, ISR03495, ISR03756, ISR04244, ISR04420, ISR05155, ISR05240, ISR05242, ISR05433, ISR05671, ISR05883, ISR05946, ISR06050, ISR06054, ISR06837, ISR06864, ISR01696, ISR02073, ISR02264, ISR02269, ISR02999, ISR03668, ISR03901, ISR04053, ISR04165, ISR04388, ISR04586, ISR04619, ISR04770, ISR04773, ISR04775, ISR04801, ISR04996, ISR05202, ISR05662, ISR05732, ISR05751, ISR06406, ISR06592, ISR07108, ISR07240, ISR07741

Distribution pattern

Worldwide Distribution - US (nationwide) and Internationally to France, Netherlands, Greece, Italy, Belgium, India, Austria, Germany, and Japan