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StatSpin Centrifuges -various models (2014-11-14)
- Starting date:
- November 14, 2014
- Posting date:
- March 27, 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-52681
Recalled Products
A. StatSpin CritSpin with digital reader
B. StatSpin CritSpin
C. StatSpin MP
D. StatSpin VT
Reason
O-Ring on RH12 rotor assembly (PN:X00-002227-001) REV B and REV BA used on the StatSpin Centrifuges may dislodge during operation and lead to a possible sample loss.
Affected products
A. StatSpin CritSpin with digital reader
Lot or serial number
All lots
Model or catalog number
M961-22
Companies
- Manufacturer
-
Iris Diagnostics, a Division of Iris International Inc.
9172 Eton Avenue
Chatsworth
UNITED STATES
B. StatSpin CritSpin
Lot or serial number
All lots.
Model or catalog number
M961-22
Companies
- Manufacturer
-
Iris Diagnostics, a Division of Iris International Inc.
9172 Eton Avenue
Chatsworth
UNITED STATES
C. StatSpin MP
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
UNITED STATES
D. StatSpin VT
Lot or serial number
All lots.
Model or catalog number
V901-22
Companies
- Manufacturer
-
Iris Diagnostics, a Division of Iris International Inc.
9172 Eton Avenue
Chatsworth
UNITED STATES