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IMMULITE 2000 and XPI (2015-03-09)
- Starting date:
- March 9, 2015
- Posting date:
- April 13, 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-52827
Recalled Products
- IMMULITE 2000
- IMMULITE 2000 XPI
Reason
Siemens Healthcare Diagnostics is conducting a correction for the Immulite 2000/Immulite 2000 XPI immunoassay systems water and liquid waste bottles received starting may 2013. Siemens has identified that the water and liquid waste bottle assemblies were manufactured with a quality issue. The smaller diameter opening of both bottles is undersized and/or deformed, preventing the cap from closing or fastening securely to the bottle.
Affected products
A. IMMULITE 2000
Lot or serial number
- M5209
- P5687
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
More than 10 numbers, contact manufacturer.
Model or catalog number
- 030002-33
- 10373214
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
62 Flanders-Bartley Road
Flanders,
07836
New Jersey
UNITED STATES