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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 67586

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

Open FDA event record

Event summary

Timeline bucket
February 03, 2014
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Siemens Medical Solutions Diagnostics

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

IMMULITE 2000; IMMULITE 2000XPi; VersaCell The IMMULITE 2000 systems are continuous random-access instruments that perform chemiluminescent immunoassays. These instruments use serum, plasma, or urine samples for in vitro diagnostic testing. The VersaCell system is a robotic sample-moving device that supports an interface to a number of laboratory analysis systems, such as the IMMULITE 2000

Z-1316-2014
Recall number
Z-1316-2014
Initiated
February 03, 2014
Classification
Class II
Status
Terminated
Quantity
1006 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for incorrect results to be reported from processing of a sample tube.

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 potential for incorrect results to be reported from processing of a sample tube.

Code information

IMMULITE 2000: 10380062, 10380061,10380079, 10380065, 10360210, 10283632 IMMULITE 2000XPi: P010053/S007; 10373214 VersaCell: 10380063, 10389945, 10380064, 10287115, 10793839

Distribution pattern

Nationwide and Foreign Distribution.