Exact FDA event identifier

Event 71473

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

Open FDA event record

Event summary

Timeline bucket: June 11, 2015
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Abbott Laboratories

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 c8000 System List Number 01G06-98 Product Usage: The Abbott ARCHITECT cSystem is intended for In Vitro diagnostic use only. It is designed to perform automated: chemistry tests, utilizing photometry and potentiometric technology.

Z-2202-2015

Recall number: Z-2202-2015
Initiated: June 11, 2015
Classification: Class II
Status: Terminated
Recalling firm: Abbott Laboratories
Quantity: 5 units

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0

does not meet specifications

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Mixed-up of materials/components

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The ARCHITECT c8000 instrument contains tubing that does not meet specifications and has the potential to leak.

Code information

Serial Numbers: C802239, C802312, C802260, C802447, C801911

Distribution pattern

US Nationwide Distribution in the states of CA, AL, NY and WI.