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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