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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 75942

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

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Event summary

Timeline bucket
November 29, 2016
Product types
Device
Classifications
Class II
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

CentraLink¿ Data Management System Software Versions: v13x,v14x,v15x The CentraLink system software is a network solution provider and multi-system data manager for the instruments and lab automation systems (LAS) within the lab. The CentraLink software consolidates data from all connected instruments so that an operator can review and edit patient and quality control results from a single location. Siemens Healthcare Diagnostics has determined that there is a remote possibility CentraLink may download an order to the ADVIA Automation System without specifying the sample type.

Z-1204-2017
Recall number
Z-1204-2017
Initiated
November 29, 2016
Classification
Class II
Status
Terminated
Quantity
3,893 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a remote possibility CentraLink may download an order to the ADVIA Automation System without specifying the sample type. This can occur when an order is received from the LIS without a sample type, requiring that the sample type be set in CentraLink based on the sample type of the test in the order.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a remote possibility CentraLink may download an order to the ADVIA Automation System without specifying the sample type. This can occur when an order is received from the LIS without a sample type, requiring that the sample type be set in CentraLink based on the sample type of the test in the order.

Code information

Product codes: 10485061, 10484212, 10485064, 10483439, 10471393, 10484552, 10814296, 10815474, 11220480, 10481936, 10481937, 10481938, 10482170, 10482936, 10483437, 10483438, 10483440, 10484211, 10484213, 10485060, 10485062, 10485063, 10703007, 10703008, 10711638, 10711639, 10711640, 10711641, 10711643, 10811596, 10811597, 10811598, 10811599, 10811601, 10811741, 10811742, 10811743, 10814298, 10814877, 10814880, 10814881, 10815694, 10816519, 10816520, 10816521, 10816522, 10816523, 10816524, 10817180, 10817181, 10819760, 10819943, 11219840, 11219841.

Distribution pattern

Worldwide Distribution - USA (nationwide) to the states of : AL, AR, AZ, CA, CO, CT FL, GA, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, WA and WV; and to the country of Canada and others.