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Statspin PM Centrifuge (SSMP) and RT12 Rotor Kit (2014-12-15)
- Starting date:
- December 15, 2014
- Posting date:
- January 7, 2015
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-43149
Recalled Products
A) Statspin PM Centrifuge (SSMP)
B) RT12 Rotor Kit
Reason
Iris International has received reports of uncontained debris (part fragments) as a result of rotor breakage and lid failures on similar centrifuge models which use the RT12 rotor and shield.
If the RT12 rotor breaks and the centrifuge fails to contain debris, escaping debris may result in possible operator injury, direct exposure to biohazardous materials, and/or loss of sample. Rotor breakage may also result in damage to the centrifuge.
Affected products
A) Statspin PM Centrifuge (SSMP)
Lot or serial number
All lots.
Model or catalog number
M901-22
Companies
- Manufacturer
-
Iris Diagnostics, a Division of Iris International Inc.
9172 Eton Avenue,
Chatsworth
91311
California
UNITED STATES
B) RT12 Rotor Kit
Lot or serial number
All lots.
Model or catalog number
Not applicable
Companies
- Manufacturer
-
Iris Diagnostics, a Division of Iris International Inc.
9172 Eton Avenue,
Chatsworth
91311
California
UNITED STATES