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Immage Immunochemistry System (2013-08-19)
- Starting date:
- August 19, 2013
- Posting date:
- January 6, 2014
- 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-37249
Recalled products
- Immage Immunochemistry System
- Immage 800 Immunochemistry System
- Reconditioned Immage
Reason
Beckman Coulter has verified that three fluid filters installed in the following locations on Immage or Immage 800 systems may prematurely fail (Clog): Reagent probe wash station, Sample probe wash station and Cuvette wash station.
Affected products
A. Immage Immunochemistry System
Lot or serial number
All lots
Model or catalog number
- 470000
- 470010
- 470664
Companies
- Manufacturer
-
Beckman Coulter Inc.
250 S. Kraemer Blvd.
Brea
92821
California
UNITED STATES
B. Immage 800 Immunochemistry System
Lot or serial number
All lots
Model or catalog number
- A15445
- A15501
Companies
- Manufacturer
-
Beckman Coulter Inc.
250 S. Kraemer Blvd.
Brea
92821
California
UNITED STATES
C. Reconditioned Immage
Lot or serial number
All lots
Model or catalog number
- 463804
- 463805
- 463812
Companies
- Manufacturer
-
Beckman Coulter Inc.
250 S. Kraemer Blvd.
Brea
92821
California
UNITED STATES