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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 73801

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

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Event summary

Timeline bucket
March 30, 2016
Product types
Device
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Siemens Healthcare Diagnostics, 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

ADVIA Centaur CP Immunoassay System, Siemens Material Number (SMN) 10309710, IVD. --- CLASSIFICATION NAME: Immunoassay Analyzers. This system is intended for professional use in a laboratory environment only. Tests performed using this system are intended for in vitro diagnostic use.

Z-1615-2016
Recall number
Z-1615-2016
Initiated
March 30, 2016
Classification
Class III
Status
Terminated
Quantity
US: 442 units; Foreign: 3237 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The firm identified an issue in sample processing when using EZee-Nest Insert Cups due to two inaccuracies that exist in the ADVIA Centaur CP Operators Guide.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Use error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The firm identified an issue in sample processing when using EZee-Nest Insert Cups due to two inaccuracies that exist in the ADVIA Centaur CP Operators Guide.

Code information

All serial numbers

Distribution pattern

Worldwide Distribution - USA (nationwide) and to the countries of : Afghanistan, Albania, Algeria, Angola, Argentina, Australia, Austria, Bangladesh, Bosnia Herzeg., Brazil, Bulgaria, Canada, Chile, China, Colombia, Czech Republic, Denmark, Ecuador, Egypt, Estonia, Finland, France, Germany, Greece, Hungary, India, Indonesia, Iran, Iraq, Israel, Italy, Japan, Kenya, Korea, Latvia, Lebanon, Libya, Lithuania, Malaysia, Mexico, Netherlands, New Caledonia, Norway, Oman, Pakistan, Peru, Philippines, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, Uganda, United Kingdom, Uruguay, Vietnam, Yemen.

Field note

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