Immulite 2000 - Instrument Class 4 and Immulite 2000-2000 XPI Instrument (2014-02-10)

Starting date:

February 10, 2014

Posting date:

March 21, 2014

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type III

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-38481

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  Reason
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  Affected products

Recalled Products

1. Immulite 2000 - Instrument Class 4
2. Immulite 2000-2000 XPI Instrument

Reason

Siemens Healthcare Diagnostics is conducting a correction for the Immulite 2000 / Immulite 2000 XPI analyzer connected to a Versacell system. There is a potential for incorrect results to be reported from processing of a sample tube if certain conditions occur on the Immulite 2000 / Immulite 2000 XPI analyzer connected to a Versacell system. This issue can only occur with versacell systems that are connected to Immulite 2000/Immulite 2000 XPI systems. This issue does not affect any other analyzer that interfaces with the versacell system. Not every instance of a dropped tube will lead to incorrect results.

Affected products