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Health product recall

IMMULITE 1000 System - Analyzer (2015-05-21)

Starting date:
May 21, 2015
Posting date:
June 10, 2015
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-53727

Recalled Products

A. IMMULITE 1000 system - analyzer

Reason

Siemens has identified a specific set of system serial numbers that may have been manufactured with a card guide that has an extra lock washer. The extra washer is not necessary when assembling the card guide and may lead to damage of the electronic chassis components. If one of these components fails, the system will become inoperable and stop sample processing.

Affected products

A. IMMULITE 1000 System - Analyzer

Lot or serial number

N3595
N3596

Model or catalog number

30006                

030006-03

Companies
Manufacturer
Siemens Healthcare Diagnostics Inc.
62 Flanders-Bartley Road
Flanders,
07836
New Jersey
UNITED STATES