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Immulite 2000 and Immulite 2000 XPI (2015-04-24)
- Starting date:
- April 24, 2015
- Posting date:
- May 21, 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-53405
Recalled Products
- Immulite 2000
- Immulite 2000 XPI
Reason
Some systems may have been manufactured with a defective reagent carousel temperature sensor PCB or you may have had a part replacement with a defective PCB assembly.
Affected products
A. Immulite 2000
Lot or serial number
All lots.
Model or catalog number
030002-13
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
62 Flanders-Bartley Road
Flanders,
07836
New Jersey
UNITED STATES
B. Immulite 2000 XPI
Lot or serial number
All lots.
Model or catalog number
- 030002-33
- 10373214
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
62 Flanders-Bartley Road
Flanders,
07836
New Jersey
UNITED STATES