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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 62709

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

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Event summary

Timeline bucket
May 29, 2012
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

syngo(R) Lab Data Manager and syngo(R) Lab Process Manager, all versions. This device is classified as a data calculator and processing module for use with In-vitro diagnostic devices. It also provides work flow management as well as remote instrument control to multiple interfaced instruments.

Z-2305-2012
Recall number
Z-2305-2012
Initiated
May 29, 2012
Classification
Class II
Status
Terminated
Quantity
44

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
When using the syngo Quality Control package the system may not perform as intended for Multi-Rule QC violation [e.g., 2(2S), 4(1s) and 10x], unless configured using the instructions on page 2 of the recall notification. QC status may not be flagged appropriately. If auto-verification rules are defined to hold patient results when QC status is out, the patient results will not be held as expecte

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

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Inspect official wording and provenance

Reason for recall

When using the syngo Quality Control package the system may not perform as intended for Multi-Rule QC violation [e.g., 2(2S), 4(1s) and 10x], unless configured using the instructions on page 2 of the recall notification. QC status may not be flagged appropriately. If auto-verification rules are defined to hold patient results when QC status is out, the patient results will not be held as expecte

Code information

Version VA11B and all previously released versions.

Distribution pattern

USA ( nationwide ) including the states of AZ, CA, FL, IL, KY, MD, MA, MN, MS, MO, NE, NH, NJ, NY, NC, OH, PA, TX, VA and WV.