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Immage 800 Immunochemistry System and Reconditioned Immage (2017-02-27)
- Starting date:
- February 27, 2017
- Posting date:
- June 7, 2017
- 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-63526
Affected Products
A. Immage 800 Immunochemistry System
B. Reconditioned Immage
Reason
Beckman Coulter has determined that Immage Cuvette Sectors (P/N 470706) may be missing one of two positioning pins. Cuvette sectors missing a positioning pin can become misaligned. If a cuvette sector becomes misaligned, under rare circumstances, the instrument mixer paddle may rub against the inside wall of the cuvette and create a noise.
Affected products
A. Immage 800 Immunochemistry System
Lot or serial number
All lots
Model or catalog number
A15445
Companies
- Manufacturer
-
Beckman Coulter Inc.
250 S. Kraemer Blvd.
Brea
92821
UNITED STATES
B. Reconditioned Immage
Lot or serial number
All lots
Model or catalog number
A36035
Companies
- Manufacturer
-
Beckman Coulter Inc.
250 S. Kraemer Blvd.
Brea
92821
UNITED STATES